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JOB OPPORTUNITIES
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OCRA makes no assurances as to the accuracy of the information provided herein. Postings made on a timely basis.
MAY 2008 POSTINGS:
Regulatory Affairs Manager - 5/15/08
Regulatory Affairs & Compliance Specialist - 5/8/08
Head of Regulatory Affairs #08-003 - 5/8/08
Manager RA, Strategies or Sr. Manager RA, Strategies - 5/8/08
Documentation Specialist, Regulatory Publishing - 5/8/08
Senior Manager Clinical Affairs - 5/6/08
Senior Regulatory Affairs Specialist - 5/6/08
Director of Regulatory Affairs - Europe - 5/6/08
Regulatory Affairs Project Manager - 5/2/08
Manager, QS Training & Implementation - 5/1/08
APRIL 2008 POSTINGS:
Regulatory Affairs Associate II - 4/25/08
Regulatory Affairs Manager - 4/25/08
Quality Engineer - 4/22/08
Senior Regulatory/Quality Specialist - 4/17/08
Product Safety Supervisor (Complaint Handling) - 4/15/08
Project Manager, Regulatory Affairs - 4/15/08
VP, RA/QA - 4/15/08
Regulatory Affairs Manager Gastroenterology/Obesity - 4/12/08
Director, Regulatory Affairs - 4/9/08
Associate Director/Director, RA - Antiviral Labeling - 4/3/08
Quality Engineer - 4/3/08
Planner/Buyer - 4/3/08
MARCH 2008 POSTINGS:
Senior Director, Regulatory Affairs - 3/31/08
Regulatory Affairs Specialist, International - 3/31/08
Principal Regulatory Affairs Specialist - 3/26/08
Director, Clinical Safety - 3/20/08
Project Manager, Clinical Marketing - 3/20/08
Clinical Research Associate II - 3/20/08
Clinical Assistant I - 3/19/08
Regulatory Affairs Assistant - 3/19/08
Director, Regulatory Affairs and Clinical Trials - 3/17/08
Quality Engineer - 3/14/08
Manager, Regulatory & Clinical Affairs - 3/12/08
Senior Quality Engineer (0801994) - 3/8/08
Regulatory Assistant - 3/8/08
Senior Safety Clinical Research Associate - 3/7/08
Global Regulatory Affairs Director - 3/5/08
Director, Global Quality Systems - 3/4/08
FEBRUARY 2008 POSTINGS:
Director, QA/RA - 2/28/08
CRA - 2/22/08
Director, Regulatory Affairs - 2/19/08
Quality Engineer - 2/7/08
Senior Regulatory Specialist - 2/7/08
Senior Clinical Research Associate - 2/1/08
Regulatory Compliance Auditor - 2/1/08
Regulatory Compliance Associate II - 2/1/08
Product Assurance Engineer - 2/1/08
Job Title: Regulatory Affairs Manager
Job Title: Documentation Specialist, Regulatory Publishing
Job Title: Senior Manager Clinical Affairs
Job Title: Senior Regulatory Affairs Specialist
Job Title: Director of Regulatory Affairs - Europe
Job Title: Regulatory Affairs Project Manager
Company Name: Branan Medical Corp.
Location: Irvine, CA
Job Type: Devices
Contact Name: Beckie
Phone:
Fax: 949-598-7167
Email: jobs@brananmedical.com
Salary: Commensurate with Exp. - Full Benefits + 410K
Job Description:
A growing company in Irvine, CA, that manufactures unique and proprietary medical diagnostic kits seeks a
Regulatory Affairs Manager. The company focuses on innovative designs, quality products and excellent service
to its clients. Jumpstart your career by applying today! Responsible for writing submission files for market
clearances such as 510Ks, CE Mark, Canadian Medical Device Licenses, etc. Control and maintain the company’s
documentation system.
Responsible for maintaining and applying for new product licenses, registrations, certifications as needed
(e.g. DEA License, Arcos Reporting, FDA State and Federal License, Canadian Medical Device Establishment License).
Conduct all governmental (FDA, DEA…etc) inspections with the inspectors. Work effectively and cooperatively
with other departments in all matters of the organization. Lead or participate in company’s internal audits.
Job Requirements:
BS in a science related field is required. 2+ years work experience in a regulated industry; Regulatory experience
in the IVD field a plus. Excellent communicator, organizer and writer. Dynamic, energetic, friendly personality.
Highly motivated to excel, detail oriented and resourceful. Ability to multi-task and work independently or with
minimal supervision. Experience in writing FDA 510K submissions, SOPs, and other documents. Experience with ISO
certification and CE Mark processes. Proficient with Microsoft Words, Excel and Adobe Photoshop.
Posted: May 15, 2008
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Job Title: Regulatory Affairs & Compliance Specialist
Company Name: IsoTis OrthoBiologics
Location: Irvine, CA
Job Type: Biologics/Biotechnology
Contact Name: Trudy Jackson
Phone:
Fax: 949-595-8703
Email: hr@isotis.com
Salary:
Job Description:
Responsible for supporting regulatory and quality assurance functions including planning and filing
of documentation with domestic and international agencies, compliance with regulations, planning related
to regulatory compliance and approvals. Will ensure that customer requirements are met.
Job Requirements:
DESIRED MINIMUM QUALIFICATIONS
Education
BS Degree in Life Sciences, engineering or related field.
Experience
Minimum five years related experience in the medical device industry.
Thorough knowledge of QSR, MDD, ISO 13485:2003, Canadian Medical Device
Regulation and AATB requirements. In depth knowledge of auditing
methods, RAC desired.
Posted: May 13, 2008
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Job Title: Head of Regulatory Affairs #08-003
Company Name: Metabasis Therapeutics
Location: La Jolla, CA
Job Type: Biologics/Biotechnology
Contact Name:
Phone: 858-622-5511
Fax: 858-622-5556
Email: jobs@mbasis.com
Salary:
Job Description:
Reporting to the CSO, this position will be responsible for providing regulatory
expertise and leadership in the design and execution of regulatory strategies in
support of corporate goals and timelines. Specific duties include:
Developing and implementing policies and objectives;
integrating strategies and policies with entire development process across disciplines;
Conducting all interactions with regulatory agencies;
Overseeing the timely preparation of regulatory submissions, and supporting documents; and
Reviewing all corporate documents, including press releases and SEC filings for compliance
with regulatory requirements.
Job Requirements:
Qualified candidates will possess:
MS in a scientific discipline; PharmD or PhD preferred
6 - 10 yrs related exp (IND, NDA submissions, in-person meetings with the FDA);
3 - 4 years in mgmt
Exp with foreign, fast-track and orphan drug filings preferred
Exp with quality control and quality assurance systems (GLP & GCP)
Demonstrated success developing regulatory strategies
Expert knowledge of US and international regulatory procedures and guidelines
Ability to interpret and apply regulations, SPA’s, and guidance documents
Demonstrated success developing positive inter-department team environments,
and building group commitments to goals and objectives.
Qualified applicants are invited to submit a resume to:
Metabasis Therapeutics, Inc.
EEO
jobs@mbasis.com
www.mbasis.com
Posted: May 13, 2008
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Job Title: Manager RA, Strategies or Sr. Manager RA, Strategies
Company Name: Teva Parenteral Medicines, Inc.
Location: Irvine, CA
Job Type: Drugs
Contact Name: Jessica Lara
Phone: 949-455-4700
Fax: 949-458-8945
Email: jessica.lara@tevausa.com
Salary:
Job Description:
Teva Parenteral Medicines is a global leader in the manufacture of generic injectable
pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Manager Regulatory
Affairs, Strategies.
Responsibilities:
* Formulates regulatory strategy and tactics for all appropriate regulatory submissions (e.g.,
ANDAs, dossiers, amendments, and supplements) for domestic, international, and/or contract
projects.
* Coordinates, prepares, and reviews all appropriate regulatory submissions (e.g., ANDAs,
dossiers, amendments, and supplements) for domestic, international, and/or contract projects
within a specified time frame in conjunction with the organization.
* Provides project management support to Labeling Specialist in development and review of draft
and final printed product labeling.
* Coordinates and reviews development of promotional labeling with Marketing.
* Coordinates and reviews for submission bi-annual Drug Listing with Regulatory Labeling
Specialist.
* Acts as contact representing Regulatory Affairs with FDA, Teva business units, contract
customers, and international customers as assigned.
* Reviews and analyzes regulatory and related publications to assure compliance and anticipate
future regulatory actions both internally and externally.
* Follows Teva Safety, Health, and Environmental policies and procedures.
* Other duties, as assigned, or as business needs require.
Job Requirements:
* Education Required: Minimum Bachelor’s degree in scientific or healthcare discipline or
equivalent combination of education and related experience.
* Education Preferred: RAPS RAC (U.S. or EU)
* Experience Required: Minimum of 5 years pharmaceutical industry experience with a least 4
years in regulatory affairs.
* Experience Preferred: Knowledge of regulatory affairs requirements for sterile drug products.
* Specialized or Technical Knowledge Licenses, Certifications needed: RAC certification beneficial,
but not required; working knowledge of CMC as needed for generic drug submissions. Prior
pharmaceutical experience involving chemistry or manufacturing.
As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of
generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for
our business.
Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental,
vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please
visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for
Position #08-2743.
Posted: May 8, 2008
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Company Name: Teva Parenteral Medicines, Inc.
Location: Irvine, CA
Job Type: Drugs
Contact Name: Jessica Lara
Phone: 949-455-4700
Fax: 949-458-8945
Email: jessica.lara@tevausa.com
Salary:
Job Description:
Teva Parenteral Medicines has an excellent opportunity for a Documentation Specialist,
Regulatory Publishing.
Responsibilities:
* Prepare to publish, publish QC FDA submission documents per eCTD Guidance and current
departmental procedures using current departmental submission software.
* Assist Regulatory Affairs professionals in the preparation of FDA submissions, i.e.
procurement of information from different departments, create document template, word
process additions/changes, and ensure formatting throughout application is consistent
with department specifications.
* Supports necessary systems for manual and electronic information collection and retrieval
related to tracking Regulatory Affairs activities (i.e., submission tracking, procurement
of Petitions, FOI requests, competitive intelligence, etc).
* As instructed; procures tracks and distributes FOI documentation for SBAs, 483s, EIRs,
suitability or citizen’s petitions, etc. When instructed, request regulatory certificates
(e.g., Appostiles, Certificates to Foreign Governments, WHO certificates of Pharmaceutical
Products, etc).
* Provide documentation electronically to other company entities and legal department as
requested. Backup to Administrative Assistant, as needed. Supports Directors, answers
phones, schedule appointments, etc.
Primary Outcomes:
* Electronic Submission to FDA formatted properly.
* Deficiency templates setup in timely manner.
* Ease in retrieving information for reporting purposes due to database maintenance.
* Information easily found due to maintenance of submission.
Job Requirements:
* Education Required: High school diploma or some college courses in Business, English, Computer
discipline or equivalent work experience.
* Experience Required: 2-3 years highly complex administrative experience: supporting high level
executive.
* Experience Preferred: 1 year in Regulatory Affairs. Understanding of regulatory guidelines
and regulations with respect to filling of regulated documents.
* Specialized or Technical Knowledge Licenses, Certifications needed: Extensive computer knowledge.
High proficiency in Lotus Notes, MS Word, and Windows. Intermediate proficiency in Excel, Access
and Power Point.
As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer
of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills
for our business.
Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental,
vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration,
please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search
for Position # 08-2826.
No relocation is offered for the position. Only local candidates will be considered. Resumes will be
reviewed and qualified candidates will be contacted for pre-screening.
Posted: May 8, 2008
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Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name:
Phone:
Fax:
Email:
Salary:
Job Description:
This is an exciting Clinical Leadership opportunity within the world leader in Heart Valves
to advance patient care through clinical research on our Trans Catheter Heart Valve Program.
• Responsible for conducting safety surveillance and reporting, including liaising with
trial CEC and DSMB for Class III PMA IDE trials in transcatheter heart valve therapy.
• Key role and strength must be to ensure compliance with GCP, US Food and Drug Administration
(FDA) or other Regulatory body regulations.
• Develop and maintain liaison among physicians/investigators, other medical professionals,
Research Organizations (CRO's), hospitals and research institutions to manage clinical
trials/studies through completion.
• Strong interpersonal and communication skills, highly accountable and detail oriented.
Job Requirements:
• A minimum of five years experience is required for the Manager level; a minimum of seven
years experience is required for the Sr. Manager level. Clinical education and experience
preferred (RN, MD, Med Tech)
• Relevant clinical trial experience in heart valve disease, coronary artery disease,
peripheral vascular disease and congestive heart failure areas required.
• Must have previous experience managing clinical projects and people.
• A bachelor's degree in a scientific or related discipline required.
• An advanced degree in related discipline and/or Professional Health Science certification
or designation a plus.
• Requires a broad cross-disciplinary and in-depth knowledge of the clinical profession; a
qualified record of implementing new clinical projects; and comprehensive written and verbal
communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational,
and follow-up skills.
• Ability to meet deadlines on multiple projects required.
• Must be able to perform in a diverse cross-functional team environment and have ability to
converse effectively with all levels of employees, management, and customers.
• A comprehensive record of delivering research information which adds value to management
decision making process.
• A demonstrated ability to understand and comply with applicable FDA regulations and Company
operating procedures, processes, policies, and tasks.
• Advanced personal computer skills including spreadsheet, word processing, database management,
power point and other necessary applications preferred.
How to Apply:
At Edwards Lifesciences, we want you to have as much information as possible before making an important
career decision. To find out more about this role and the opportunity it offers, please visit our website:
www.edwards.com
OR
To apply directly to this position, please click the link below or cut and paste it into your browser:
http://www.edwards.com/Careers/reqfinder?urlvariablestring=2692
Posted: May 6, 2008
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Company Name: Confidential
Location: Los Angeles, CA
Job Type: Devices
Contact Name: Lewie Casey
Phone: 818-552-2036 or 800-507-5277 ext 424
Fax:
Email: lcasey@medexecintl.com
Salary: Industry Competitive
Job Description:
Prepare and maintain 510(k), IDE, PMA submissions, supplements, and annual reports to
obtain and maintain approvals for conducting clinical investigations and for commercially
distributing products worldwide.
Job Requirements:
Experience/ Requirements:
• B.S. in scientific discipline or engineering
• A minimum of 3-5 years of worldwide medical device regulatory experience
• Experience writing RA submissions
• Class II and Class III medical device R & D and manufacturing experience is a plus
• RAPS certification is a plus
Posted: May 6, 2008
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Company Name: Confidential
Location: London, UK
Job Type: Drugs
Contact Name: Rosemarie Christopher
Phone: 818-552-2036/800-507-5277 x213
Fax: 928-585-2036
Email: rosechristopher@medexecintl.com
Salary: Industry Competitive
Job Description:
Responsibilities:
• Provide vision, direction and management of the Regulatory Affairs professionals
• Provide senior oversight on regulatory projects and ensure the timeliness and quality of
communications with external agencies and clients
• Develop & implement the Global Regulatory function/plans
• Successfully pilot an innovative rapid start up Common Training Architecture (CTA) management process
• Review revenue budgets and have a creative input as to shifting of resources, allocations, etc.
• Make presentations to sponsors, develop and review bids and proposals, and conduct contract negotiation
through to closure with the sponsor
• Ensure compliance with relevant organizational and Regulatory Affairs Standard Operating Procedures and
Working Practice Documents
Job Requirements:
Requirements/Education:
• B.S. in Chemistry, Biochemistry, or related field; advanced degree preferred
• 2+ years of experience in managing regulatory affairs
Posted: May 6, 2008
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Company Name: MicroVention, Inc.
Location: Aliso Viejo, CA
Job Type: Devices
Contact Name: Juli Evans
Phone: 949-461-3314, x1334
Fax:
Email: julie@microvention.com
Salary:
Job Description:
Scope:
Assists the Director, RA with management of regulatory submissions and compliance programs for
new products on a world-wide basis.
Responsibilities:
1.Plays a key role in the preparation of regulatory submissions (e.g. 510(k)s, Design Dossiers;
potentially IDEs and PMAs) for intravascular, catheter-based products
2.Participates in hosting outside regulatory bodies during plant inspections
Job Requirements:
Skills:
1.Concentrated knowledge of U.S., EC & Canada regulatory submission requirements
(510(k)s, Design Dossiers)
2.Strong knowledge of FDA QSR, ISO 13485:2003 & Health Canada
3.Excellent communication, writing and team-building skills
Requisite Experience:
1.BA/BS in Science, Engineering or Medical Technology
2.Five to seven years experience in Regulatory Affairs
3.Strong knowledge of Regulatory submission and compliance requirements for the US, Canada,
European, and other international markets, for sterile, intravascular catheters and implants
Please email resume in MS Word format to
julie@microvention.com or fax resume to 949.362.0968, Attn: HR Department. Thank You!
We are proud of our diverse environment, EOE, M/F/D/V. MicroVention, Inc. is an equal opportunity
employer.
Posted: May 2, 2008
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Job Title: Manager, QS Training & Implementation
Company Name: Allergan
Location: Irvine, CA
Job Type: Devices, Biologics/Biotechnology
Contact Name:
Phone:
Fax:
Email:
Web:
http://www.allergan.com/careers/job_search.aspx
Salary:
Job Description:
Reporting to the WWQA Director of Device Quality and Risk Management, the incumbent has
primary responsibilities for the WWQA Quality System implementation and training. Develop
training material and program to support the WWQA Quality System, and assist in the integration
of Allergan Quality System. Review industry trends including updates to FDA/ISO and alternate
MOH/notified body guidances to ensure that Allergan Quality System remains current and to develop
communication aide (not limited to formal training) to assure compliance. The WWQA Training
Program shall include training for Irvine based employees for WWQA Quality System, FDA,
alternate MOH, and ISO Regulations, Design Controls, and Risk Management. Liaise with Irvine
based trainers from alternate departments and trainers at GTOPS manufacturing facilities
and alternate Allergan sites in support of ongoing activities for standardize of Quality
System training programs and monitor the effectiveness and timeliness of training. Support
ongoing activities for maintenance of the Quality System; performing gap analysis, document
revisions, ensuring training materials and any software utilized for training tracking and
trending is appropriate for use. Monitor the effectiveness of the Quality System.
Job Requirements:
Education and Experience:
1. Bachelors degree in chemistry, microbiology, or related health care industry field of study.
2. GMP/Quality Systems experience.
3. Experience in relation to development of training materials.
4. Public speaking experience.
5. Knowledge of worldwide regulations and systems as they relate to domestic and off-shore
manufacturing. This level of knowledge would normally be acquired through 8 – 10 years of
Quality Control/Quality Assurance and/or Regulatory experience in a management position that
provides support to worldwide production facilities.
6. Proven ability to lead and manage people in a matrix environment.
Thorough knowledge of quality and regulatory matters relating to drugs and devices with an
ability to manage the “gray” area where important decisions must regularly be made. This
level of knowledge would normally be acquired through 6 – 8 years of Quality Control/Quality
Assurance and/or Regulatory experience in successive management positions in a drug manufacturing
concern or equivalent experience in Production/Regulatory/Research.
Please apply online using the following link:
http://www.allergan.com/careers/job_search.aspx
AA/EOE M/F/D/V
Posted: May 1, 2008
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Job Title: Regulatory Affairs Associate II
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name:
Phone:
Fax:
Email:
Salary: D.O.E.
Job Description:
Represent Regulatory Affairs on new product development and manufacturing support
teams. Prepare document packages for submission to global regulatory agencies
(IDEs,annual reports, 510(k)s and CE marking design dossiers and technical files).
Prepare IDE annual reports and Justifications to File.Assume regulatory review of
labeling content, product and process changes and product documentation.
Make presentations to management teams.
Job Requirements:
- Experience with class III medical devices, cardiovascular devices, critical care
and/or vascular surgery devices is a plus.
- Experience in preparing domestic FDA and EU product submissions, with experience in
preparing submissions for Canada and Australia a plus.
- Demonstrated competence in determination of appropriate global regulatory requirements
for new products or product changes.
- Bachelor of Science degree in a scientific
discipline or related field is required.
- Requires familiarity with new product development systems; a strong working knowledge
of all U.S. regulations that affect Class II and Class III devices; a strong understanding
of global regulations; excellent writing and verbal communication skills; and strong
problem-solving and analytical ability.
At Edwards Lifesciences, we want you to have as much information as possible before making an
important career decision. To find out more about this role and the opportunity it offers,
please visit our website: www.edwards.com
or
To apply directly to this position, please click the link below or cut and paste it into your
browser: http://www.edwards.com/Careers/reqfinder?urlvariablestring=2763
Posted: April 25, 2008
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Job Title: Regulatory Affairs Manager
Company Name: Newport Medical Instruments, Inc.
Location: Costa Mesa, CA
Job Type: Devices
Contact Name: Suzette Matsufuji
Phone: 714-427-5811 x215
Fax: 714-429-8810
Email: smatsufuji@nmitkb.com
Salary:
Job Description:
The Regulatory Affairs Manager will be responsible for managing the
regulatory submissions associated with new and revised designs.
Submissions include US 510(k)s, Technical Files for CE marking,
Canadian Medical Device Registrations files, and Australian TGA
submissions. Will also be responsible for working with Japan
affiliates on submissions in accordance with the Japan PAL. The RA
manager will also be responsible for providing documentation in
support of country specific product registrations as well as FDA
registrations and listings. Will be responsible for device tracking
orders and post market requirements as required for product approvals.
The Regulatory Affairs Manager will be an integral part of design teams,
assisting with development of project plans for new product introductions
and modifications to existing devices. Will work with Marketing and
Clinical Support on labeling and advertising development and approval.
Job Requirements:
Background Required: Bachelors degree or higher required, biological or
engineering major preferred. At least 3 years of medical device experience
with Class II or Class III devices and submissions. Must have successful
track record with submissions written recently.
Technical Skills Required: Understanding of US Quality System Requirements
for Medical Devices and CE marking requirements for EU. Understanding of
Canadian, Australian and Japan Medical Device regulations desired.
Work style: Independent worker, self directed, able to manage details while
keeping project and business objectives in focus. Must have strong written and
verbal skills with strong leadership skills. Ability to multi-task in a quick
paced environment is a must. Strong organizational skills required to maintain
files and documentation.
Computer Skills: Microsoft Office. Visio and Project desired.
Posted: April 25, 2008
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Job Title: Quality Engineer
Company Name: Sakura Finetek USA, Inc.
Location: Torrance, CA
Job Type: Devices
Contact Name: Betty McDonald
Phone: 310-972-7808
Fax: 310-782-7495
Email: bmcdonald@sakuraus.com
Salary: DOE
Job Description:
General Position Summary
Designs and coordinates the effective implementation of quality/reliability goal oriented programs
supporting the pre-production, production and post production phases of operations under moderate
guidance and supervision. Studies engineering drawings, specifications and user requirements to
determine appropriate quality procedures and techniques are applied to assure cost-effective
compliance with tolerances, material standards and product performance requirements. Supports
company-wide implementation of continuous improvement programs.
Essential Job Functions
Quality Engineering Activities
§ Prepares quality plans, procedures and instructions in accordance with QA policies and stated
requirements of specific program contract specifications.
§ Participates in design/process reviews, evaluates the need for possible inspection tooling and/or
test equipment.
§ Reviews manufacturing and assembly planning for appropriate sequenced quality requirements.
Prepares appropriate check lists for quality control points throughout the manufacturing/assembly
processes.
§ Act as direct quality liaison with Engineering, Manufacturing, Assembly, Procurement, suppliers and
customers. Performs inventigative research with discrepant materials and quality processes; compiles
information analyzes issues related to the root causes and initiates corrective action.
Job Requirements:
Education
B.S. in Mechanical, Industrial or Electrical Engineering or equivalent combination of education and
experience.
Experience & Minimum Qualifications
§ Three (3) to Five (5) years experience in manufacturing environment with a minimum of three (3) years
as Quality Engineer.
§ ASQ certification as Quality Engineer or Six Sigma Black Belt desired.
§ Must be familiar with ISO 9001 and ISO 13485 requirements.
§ Medical device manufacturing experience preferred.
§ Good analytical and problem resolution skills related to electro-mechanical products and manufacturing
processes.
§ Good knowledge and skills in the use of advanced personal computer productivity programs for word
processing, spreadsheets, database manipulation and flow charts.
§ Demonstrates reasoning ability and decision making skills to apply principles of logical or scientific
thinking to a wide range of intellectual and practical problems.
§ Demonstrate the ability to deal with a variety of abstract and concrete variables for problem solving
activities.
Posted: April 22, 2008
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Job Title: Senior Regulatory/Quality Specialist
Company Name: eVent Medical
Location: Aliso Viejo, CA
Job Type: Devices
Contact Name: Robert Lundberg
Phone: 949-360-4248 x232
Fax: 949-360-1924
Email: hr@event-medical.com
Salary: Commensurate with exp $80-$90K
Job Description:
This is an outstanding Regulatory/Quality position with a growing Orange County Medical Device company where you will be able
to quickly advance your career in domestic and international regulatory and quality roles.
You will be responsible for providing assistance in supporting the process of meeting requirements established by US and
international governmental agencies related to introducing new and modified medical devices to market. This will involve
hands-on activities in our Aliso Viejo, CA; Galway, Ireland and Buchs, Switzerland locations. You will plan and prepare
510K FDA and international submissions as well as a host of other regulatory and quality assignments. Please see the
position details.
We are offering a competitive salary with a
comprehensive benefits
package and a small-business, team-oriented work environment.
Job Requirements:
DESIRED MINIMUM QUALIFICATIONS:
• BS/BA (Life Sciences or Engineering preferred) with 3-5 yrs of experience in medical device regulatory and quality assurance
with Class II and/or III Medical Devices
• Experience in direct interaction with FDA and Notified Bodies
• Comprehensive knowledge of FDA Quality System regulations and ISO 13485:2003/MDD requirements, Canadian Medical Device
Regulations, Medical Device Regulations in Japan and other international regulatory requirements as indicated.
• Familiarity with FDA device regulations; 510K experience a plus.
• Regulatory Affairs Certified; Member RAPS
• Member ASQ
RELATED BUSINESS/ TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
• Accuracy and detail orientation extremely important
• Ability to use independent judgment and manage projects and/or staff with minimal supervision
• Solid organizational skills and time management skills
• Excellent verbal and written communication skills
• Ability to provide recommendations to supervisor
Posted: April 17, 2008
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Job Title: Product Safety Supervisor (Complaint Handling)
Company Name: Advanced Medical Optics, Inc.
Location: Santa Ana, CA
Job Type: Devices
Contact Name: To apply, please use URL below.
Phone:
Email:
Website:
https://amo.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=0801001E
Job Description:
Advanced Medical Optics, Inc. (AMO) (NYSE: EYE) is a global medical device leader focused on the discovery and delivery of
innovative vision technologies that address a wide range of eye disorders and optimize the quality of life for people of
all ages.
With corporate offices based in Santa Ana, California, we have operations in 24 countries and market our products in
approximately 60 countries. We employ approximately 4,200 people worldwide and are committed to building and maintaining a
workforce that reflects the diversity of our global customer base. We value the unique talents and perspectives of our
employees and invite candidates with diverse backgrounds to take a closer look at our company and help achieve our vision of
the future. Together, we can provide "Vision. For Life."
Job Requirements:
Supervisor of Product Safety
We are looking for a talented and motivated individual to join the AMO Product Safety and Compliance team. The chosen
candidate will be responsible for the direct supervision of complaint handling analysts for AMO vision care laser products
including excimer and femtosecond laser systems. Supervise analysts and actively participate in complaint procedural inquiries
and investigations to determine cause of customer complaints, and identify any quality problems. Develop Medical Device Reports
and Vigilance Reports as necessary in a timely manner for regulatory submissions.
Qualifications
Bachelor Degree and 6+ years of related work experience
Opthalmic lasik experience highly desirable but not mandatory
Knowledge and experience with Medical Device Reporting and Vigilance
Reporting for medical equipment or medical devices.
Working knowledge of statistics. Software efficiency in Excel
Advanced Medical Optics offers a competitive salary and generous benefits package. This includes healthcare coverage, 401 (k),
supplemental retirement contributions to the 401k Plan, employee stock purchase plan and much more. At AMO, people make the
difference and have the opportunity to be a part of a global company that is a major force in the medical device industry.
AA/EOE M/F/D/V
Posted: April 18, 2008
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Job Title: Project Manager, Regulatory Affairs
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name:
Phone:
Fax:
Email:
Salary: D.O.E.
Job Description:
Represent Regulatory Affairs on the Renaissance Team for Design History File remediation. This will
be an approximately 100% job assignment for the approximately one year that the team will operate.
Subsequently, the person's job responsibilities will change so that the person will represent
Regulatory Affairs on various R&D or manufacturing-related projects requiring a high level of
regulatory affairs knowledge and experience.
Project involves, as a member of the team, developing retrospective Design Requirements Documents and
then ensuring the Design traceability Matrixes are fully populated with supporting documentation that
meets current Edwards Lifesciences requirements. In the future, will represent Regulatory Affairs on
new product development and manufacturing support teams. In the future, will prepare document packages
for submission to global regulatory agencies (IDEs, PMAs, annual reports, 510(k)s and CE marking design
dossiers and technical files). Prepare IDE and PMA annual reports and Justifications to File. In the future,
will assume regulatory review of promotional material, labeling content, product and process changes and
product documentation.
In the future, will act as liaison with government officials in support of product approvals. Make
presentations to management teams. Mentor Renaissance Team members with regard to regulatory requirements.
Job Requirements:
Multi-level position: Position title and level posted is preferred. However, depending on background
and experience, we will consider hiring at the Sr. Project Manager, Regulatory Affairs level. The
Project Manager, Regulatory Affairs requires a minimum of eight years experience in Regulatory Affairs
with a BS degree, preferably in a scientific discipline.
The Senior Project Manager, Regulatory Affairs requires a minimum of ten years experience with BS
degree, preferably in a scientific discipline, or eight years experience with an MBA or related Master's
degree.
Experience in preparing domestic FDA and EU product submissions required, with experience in preparing
submissions for Canada and Australia a plus.
Demonstrated competence in working as part of a focused, long-term project team.
Demonstrated competence in determination of appropriate global regulatory requirements for new products or
product changes.
Demonstrated understanding of basic regulatory requirements for promotional materials.
Experience in review and approval of promotional materials is a plus.
Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations
that affect Class II and Class III devices; a strong understanding of global regulations; excellent writing
and verbal communication skills; and strong problem-solving and analytical ability.
To apply directly to this position, please click the link below or cut and paste it into your browser:
http://www.edwards.com/Careers/reqfinder?urlvariablestring=2718
Posted: April 15, 2008
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Job Title: VP, RA/QA
Company Name: VC backed IVD/Device Company
Location: Costa Mesa, CA
Job Type: Devices
Contact Name: Julia Kaplan
Phone: 858-229-7300
Fax:
Email: jkaplan@juliakaplan.com
Salary: negotiable
Job Description:
Ideal candidate would have PMA experience.
This person will have responsibility for RA/QA/QC and will act as Company representative
with regualtory agencies as the organization prepares for its first PMA.
The VP RA/QA will build the Regualtory and Quality deparment and determine long term
strategy.
Company backed by several venture capitalist firms inclduing, Burrill & Company
and New Leaf Ventures.
Posted: April 15, 2008
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Job Title: Regulatory Affairs Manager Gastroenterology/Obesity
Company Name: Allergan Medical
Location: Goleta, CA
Job Type: Devices
Contact Name: Trevor Pritchard
Phone:
Fax:
Email: tpritchard@strawnarnold.com
Salary:
Job Description:
The Company
Allergan, Inc. (www.allergan.com) is a $3.9 billion revenue multi-specialty health care
company focused on discovering, developing and commercializing innovative pharmaceuticals,
biologics and medical devices in the ophthalmology, neurosciences, medical dermatology,
medical aesthetics, obesity intervention, urologics and other specialty markets.
Responsibilities
Based in Santa Barbara, California, and reporting to the Senior Director of U.S. Regulatory
Affairs of Allergan Medical, the Regulatory Affairs Manager will be responsible for the
preparation of regulatory submissions for U.S. regulatory filings as well as provide oversight
and day-to-day regulatory support for the Company’ marketed and development stage Gastroenterology
and Obesity Intervention Products. This role will include the regulatory oversight over the
LAP-BAND® System for obesity intervention treatment. In addition, the incumbent will:
* Drive the management and timely presentation and submission of all IDE’s, PMA’s, 510(k)’s
under his/her responsibility. Provide support, as necessary, to corresponding international
registration packages. This includes the maintenance of all files under his/her area of
responsibility, guidance of regulations and the pertinent documents as well as the coordination
of post-market approval activities required to conform with regulatory requirements.
* Represent Regulatory Affairs Department and participate as a member of product development
teams to coordinate all regulatory activities.
Job Requirements:
Qualifications
The ideal candidate will have a scientific background and relevant experience in regulatory
affairs.In addition, the successful candidate will possess:
* Relevant experience with Class III medical devices.
* Previous or actual experience working in a large established medical products company.
* Demonstrated leadership competencies manifested through persuasive influencing, solid
organizational, sound negotiation, reasoned judgment, and effective interpersonal skill sets.
* Knowledge of FDA’s Quality Systems Regulation 21 CFR Part 820, ISO 13485:2003, Council
Directive 93/42/EED (Medical Device Directive), and the Canadian Medical Devices Regulations;
1998.
* Ability to coordinate and synchronize multiple projects and be flexible in changing daily
workload priorities.
* Experience in computer literacy including storage and electronic submission of documents/files
to the FDA.
* Ability to communicate effectively, orally and in writing, with all internal and external
contacts.
Compensation
An attractive compensation package will be offered to the successful candidate. It will
include a competitive base salary, an incentive bonus, and, as required, a relocation package.
A benefits package customary to a position of this importance and significance will also be
provided.Allergan Medical, Div. of Allergan, Inc.
Posted: April 12, 2008
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Job Title: Director, Regulatory Affairs
Company Name: ATS Medical, Inc.
Location: Minneapolis, MN
Job Type: Devices
Contact Name: Human Resources
Phone: 763-553-7736
Fax: 763-557-2272
Email: human.resources@atsmedical.com
Salary:
Job Description:
The primary purpose of this position is to plan and implement domestic regulatory submissions (OUS).
The position is responsible for the direction of domestic Regulatory Affairs activities for ATS
Medical, Inc. Responsibilities include planning, implementation, execution and management of programs
in the above areas consistent with Company objectives.
Job Requirements:
Qualified candidates will have a Bachelor’s degree in Engineering, Biomedical, or Life Sciences and a
minimum of five (5) years of experience in management experience and regulatory affairs in Class II
and III in the Medical Device Industry. Experience of direct relationship and involvement dealing with
International regulatory agencies related to applications and submissions, preparation and follow-up on
the following: Design Dossier applications; Technical Files; Country Applications for registration and
approval; CE Mark; International submissions; Serious Adverse Events/Vigilance reports/Complaints, and
other related regulatory matters. Broad working knowledge, specifically in the areas of statistical
applications, reliability engineering, regulatory compliance programs, design and development projects
and Clinical studies. Good technical writing. Program (project) management experience. Experience
with clinical programs.
Posted: April 9, 2008
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Job Title: Associate Director/Director, RA
Company Name: Confidential
Location: San Francisco, CA
Job Type: Biologics/Biotechnology
Contact Name: Cheryl Jones
Phone: 818-552-2036 x412
Fax:
Email: recruit@medexecintl.com
Salary: Industry Competitive
Job Description:
Perform the procurement of materials, parts, equipment, and supplies for the assigned business
areas while negotiating with suppliers for the best cost, quality and timely delivery of products
and services.
Responsibilities:
Summary:
Provide quality and reliability engineering support to all aspects of operations.
Responsibilities
Responsible for the creation, management and maintenance of the Company Core Data Sheets (CCDS)
for assigned products and for ensuring that any updates to the CCDS are implemented in a timely
manner.
Responsibilities:
• Responsible for providing strategic and operational leadership in the area of labeling
primarily pertaining to antiviral products
• Responsible for the creation and maintenance of US labeling for assigned products and manage
the review and approval of such labeling prior to submission to the US Food and Drug Administration
• Work closely with senior personnel from Marketing, Legal, Medical Affairs and Clinical Research
and other functional areas, as applicable
• Serve as the principle Regulatory Affairs, Labeling representative on Regulatory Project and
Submission Teams and work closely with regional regulatory affairs’ liaisons towards the approval
of original labeling and submission of updates to product labeling
• Provide expertise in the interpretation of regulations and guidance and implementation of best
practices and standards as they apply to product labeling.
Job Requirements:
Education/Experience:
• BA/BS in a relevant discipline and minimum 12 years of relevant experience in RA, or an MS/PhD in a
relevant discipline and a minimum of 8 to 12 years of relevant experience in RA is preferred
• Experience representing Regulatory Affairs on project teams is required
• Experience working directly in the area of product labeling is required
• In-depth working knowledge of regulations and guidance and their implementation in the area of
labeling and experience supporting multiple commercial products are required.
• Previous people management experience and direct experience working with Regulatory Authorities in
assigned territories is required
• Extensive knowledge of regulatory requirements, including ICH requirements and regional
requirements for assigned territories and have an understanding of current global and regional
trends in Regulatory Affairs
• Must be capable of developing and implementing regulatory strategy and of managing complex
negotiations with Regulatory Authorities
• Must be capable of taking a leadership role in updating and preparing the Company for major
changes in legislation in assigned territories, which impact many departments
• Must be capable of leading one or more teams in preparation of submissions and maintenance of
licenses
• Ability to act as an expert resource for Regulatory Advice in other departments
• Expert knowledge of the pharmaceutical business and proficiency at representing/interpreting
the strategic business objectives of the company
• Experience with the submission of electronic labeling is highly desirable.
Posted: April 3, 2008
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Job Title: Quality Engineer
Company Name: Confidential
Location: Irvine, CA
Job Type: Devices
Contact Name: Cheryl Jones
Phone: 818-552-2036 x412
Fax:
Email: recruit@medexecintl.com
Salary: Industry Competitive
Job Description:
Perform the procurement of materials, parts, equipment, and supplies for the assigned business
areas while negotiating with suppliers for the best cost, quality and timely delivery of products
and services.
Responsibilities:
Summary:
Provide quality and reliability engineering support to all aspects of operations.
Responsibilities
• Ensures that the products are tested in accordance with ISO and FDA guidelines
• Designs, procures, maintains, and implements test fixtures and support equipment to perform
testing requirements.
• Writes test protocols, validation reports, inspection procedures, and test methods associated
with current and new products or processes.
• Coordinate the testing of products in accordance with these documents.
• Analyzes failed test samples, investigates, and reports findings.
• Assures flow of testing information and provides this information to Manufacturing and Quality
departments.
• Conducts DOE and FMEA activities.
• Responsible for product evaluations and/or investigations associated with complaints and the
corrective action system.
Job Requirements:
• BS/BA degree in Engineering or Chemistry
• 2+ years related experience in the medical device industry or ISO certified company
• Silicone and coating experience preferred
• CQE and/or CQA preferred
• Demonstrated hands-on work approach and examples of hands-on involvement in prior work position
• Persistence and ability to resolve problems
• Effective verbal, written, analytical, computer and interpersonal skills
• Understanding of Statistical techniques, DOE, and process improvement technique
Posted: April 3, 2008
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Job Title: Planner/Buyer
Company Name: Confidential
Location: Irvine, CA
Job Type: Devices
Contact Name: Cheryl Jones
Phone: 818-552-2036 x412
Fax:
Email: recruit@medexecintl.com
Salary: Industry Competitive
Job Description:
Perform the procurement of materials, parts, equipment, and supplies for the assigned business
areas while negotiating with suppliers for the best cost, quality and timely delivery of products
and services.
Responsibilities:
• Support business operations through procurement of production items, MRO items and business
services
• Establish short and long-term purchase orders that provide the best terms and least liabilities for
products procured
• Negotiate cost, quantity and delivery with suppliers to provide the best price/quantity
• Perform a level of production planning for assigned areas to meet production goals for products
• Process requisitions for non-production item and coordinate returned goods to suppliers
• Interpret and execute ERP system generated messages for planning and procurement
• Make recommendations to engineering/management on modification to items procured to facilitate ease
of manufacture by the supplier, while maintaining cost, quality and delivery objectives
• Keep abreast of changes in the market that may affect company’s position for procurement of products
• Communicate expected late deliveries to production in a timely manner
• Negotiate the earliest possible delivery to meet production/business needs
• Communicate product non-conformities to the appropriate engineering personnel
• Mediate changes that enable suppliers to meet cost, quality and delivery objectives
• Travel to assist in supplier surveys and perform prescreening of suppliers
• Coordinate first article inspections with suppliers to assist in determining the supplier’s ability
to meet company product quality requirements
• Review the status of late open orders and perform the necessary follow-up to ensure the cost-effective
receipt of quality products
• Interface with receiving inspection to facilitate the processing of materials that require
purchasing department attention
• File and maintain documentation in an appropriate manner to facilitate traceability of records
associated with the purchasing function
• Adhere to all regulating agency guidelines, i.e. FDA, ASME, PVHO, etc.
Job Requirements:
• Bachelor’s degree from four-year college or university; and
• 5-7 years related experience and/or training as a Buyer or equivalent; or
• Equivalent combination of education and experience
• Experienced in Microsoft Office Programs
• Effective oral and written English communication skills, Fluent in Mandarin Chinese a plus
• Ability to add, subtract, multiply, and divide in all units of measure
• CPM, ISM, and/or CPIM Certificate a plus
Posted: April 3, 2008
Job Title: Senior Director, Regulatory Affairs
Company Name: San Diego Biotech
Location: San Diego, CA
Job Type: Drugs
Contact Name: Julia Kaplan - Executive Recruiter
Phone: 858-=229-7300
Fax:
Email: jkaplan@juliakaplan.com
Salary: Negotiable
Job Description:
Ideal candidate would have blend of both regualtory experience in CMC and Clinical Development.
This position is responsible and accountable for regulatory participation and contribution on
product and project teams. Responsibilities include preparation of regulatory information,
submissions and documents, and performing regulatory activities in the preparation of NDAs and
MAAs. Responsible for developing strategies/timelines, conducting meetings, acting as liaison
with regulatory authorities, participating in inspections, budgeting, and presenting project
plans to management. Works closely with functional areas such as Clinical Development, Project
Management, Manufacturing, and Quality Groups.
Job Requirements:
Having NDA electronic submission experience would be ideal. Phase III experience also a plus. Must be
comfortable with face to face meetings with FDA.
Posted: March 31, 2008
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Job Title: Regulatory Affairs Specialist, International
Company Name: Masimo
Location: Irvine, CA
Job Type: Devices
Contact Name: Ed Klimczak
Phone: 949-297-7511
Fax:
Email: eklimczak@masimo.com
Salary: DOE
Job Description:
Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning
international medical technology and device company with operations spanning the globe. We
develop innovative, noninvasive monitoring technologies that save, extend and improve the lives
of people of all ages, in all walks of life. These revolutionary technologies are helping to solve
"unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort
out of blood monitoring. For almost 20 years, innovation has been and will continue to be our passion.
To learn more about us, please visit: www.masimo.com
REGULATORY AFFAIRS SPECIALIST, International
In this high profile role, you will be an integral part of an expanding regulatory affairs team that
is responsible for maintaining and documenting our mission critical international regulatory filings
and registrations! From coordinating with international regulatory team members on product changes to
maintaining up-to-date knowledge on international regulatory requirements, you will be the point person
in making it happen! Your organizational ability and multi-tasking skills will be rewarded with
opportunities for career growth and advancement in a company that makes a difference in people’s lives!
Responsibilities
• Support international filings/registrations
• Coordinate with international regulatory team members on product changes
• Maintain product list on Certificate of Foreign Government
• Coordinate with Customer Support/Shipping product name consistency
• Maintain up-to-date knowledge on international regulatory requirements
• Maintain RoHS/WEEE compliance for all products
• Track component certifications and supplier surveys
• Generate Declaration of Conformity
Job Requirements:
• BA/BS Degree or equivalent
• Minimum 2-5 years of work experience in a related field
• Proficient in MS Office (Word/Excel/Access/Outlook)
• Good verbal and written communication skills
• Good prioritizing, organizational, and interpersonal skills
• Ability to work in a fast-paced environment with multiple tasks/projects
Preferred Education/Skills:
• Experience with working in business environments such as legal firms and/or medical device
companies
• Experience with FDA/GMP requirements for medical device
• Experience with UL/ETL certification process
• A detail-oriented individual with a “can do” attitude
We are proud to offer a highly competitive compensation plan with an excellent benefits package
including stock options, 401k match, medical, dental, vision plans and much more!
Posted: March 31, 2008
Job Title: Principal Regulatory Affairs Specialist
Company Name: Medtronic
Location: Santa Ana, CA
Job Type: Devices, Biologics/Biotechnology
Contact Name: online only
Phone:
Fax:
Email:
Website:
Salary: (Market)
Job Description:
What is it like to spend your day restoring health to people around the world?
It’s challenging. It’s energizing. It’s rewarding. That’s why our nearly 38,000 employees around the world have
chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions
for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved
by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and
discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 11 years.
Principal Regulatory Affairs Specialist
Description
For this position, you will develop strategies for and lead the implementation of new product introductions and product
changes to the market, negotiating their worldwide approval with governmental agencies such as the FDA before submission.
When necessary, you will provide support for currently marketed products, including reviewing labeling, promotional material,
product changes and documentation for changes requiring government approval. You will prepare reports for the FDA and maintain
product files. You will also provide expertise of regulatory requirements to personnel and supervise their work on large-scale
projects.
Job Requirements:
Basic & Preferred Qualifications
Qualified candidates must have a bachelor’s degree, preferably in engineering or physical/biological science, and 8 years’
industry experience, including 3 years’ regulatory experience with Class III devices. You must be proficient with regulatory
planning/strategy and worldwide regulatory requirements and procedures; have strong negotiation skills and knowledge of Medtronic
product design, manufacturing and development systems; and have submissions-related WP skills. We prefer that you are familiar
with in-vitro diagnostics and have regulated clinical experience.
TO APPLY: Submit your resume at
www.medtronic.com/employment. Enter Req ID: #61551, review job description and select "Apply to
Selected Job" to route your resume directly to the hiring department. No agencies or phone calls, please.
Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.
Posted: March 26, 2008
Job Title: Director, Clinical Safety
Company Name: Johnson and Johnson
Location: Diamond Bar, CA
Job Type:
Contact Name:
Phone:
Fax:
Email:
Website: www.jnj.com/careers
Salary:
Job Description:
The Clinical Safety Director will be responsible for the Clinical Safety Issues Management such as
Medical complaint/adverse event investigation, follow-up, and clinical input to quality boards/health
hazard assessment. Will handle product development support and medical risk management support (e.g.,
FMEA, risk analyses, product inserts.) The candidate will handle evaluation of medical/surgical
application of new technologies and procedure and focus on guiding new franchise areas (i.e., GI/Ther
Endo, Oncology).
Job Requirements:
This individual will obtain external expert opinion for new or emergent issues and assure appropriate
clinical input to Medical Device Reports (MDR) to FDA or equivalent. In the area of Risk Management, the
Clinical Safety Director will assure appropriate and consistent evaluation of potential hazards associated
with product attributes and/or failure of BWI’s devices or manufacturing processes. The candidate will maintain
knowledge and awareness of the field of electrophysiology as it pertains to the products; transmitting this
information to appropriate teams or individuals, and keeping the company informed as to safety considerations
associated with our products.
As a valued team member, you’ll receive a competitive salary and great benefits including medical/dental, a 401(k),
a pension plan and a comprehensive wellness program. If interested, please apply directly on-line at our web site
www.jnj.com/careers noting Req. Code 0716871. Johnson & Johnson has a strong commitment to diversity and welcomes
applications for all individuals. EOE M/F/D/
Posted: March 20, 2008
Job Title: Project Manager, Clinical Marketing
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name: Patty Vasquez
Phone:
Fax:
Email: patty_vasquez@edwards.com
Salary: d.o.e.
Job Description:
Embark on an exciting opportunity within the world leader in Heart Valves to advance patient care
through clinical research on our Transcatheter Heart Valve Replacement Program. The Project Manager’s
primary responsibility is the creation of training materials for transcatheter heart valve program.
• Facilitate training programs for physicians and staff in the cardiac catheterization laboratory and
operating rooms related to the transcatheter valve procedures.
• Collaborate with Edwards Lifesciences consultants on the continuous evaluation and improvement of the
training programs.
• Maintain an ongoing relationship with the EW training teams for standardization of the training programs.
• Facilitate communication of key learning between implanting physicians as procedures develop.
• Develop and implement a train-the-trainer program for proctors and Clinical Specialists.
• Bring feedback to the R&D team in the development and improvement in procedures and devices.
• Develop SOPs for all aspects of training on the transcatheter valve programs. Maintain documentation related
to training programs for the transcatheter programs.
Job Requirements:
• Requires a minimum of five years experience in the medical field or medical device industry.
• A bachelor's degree is required.
• Knowledge of CV surgery and cardiac catheterization laboratory preferred.
• Excellent organizational and time management skills required.
• Proven ability to work well with key thought leaders in the medical field is essential.
• Must be proficient in computer skills.
• Requires 25-50% travel. Primarily domestic but occasional international travel.
Posted: March 20, 2008
Job Title: Clinical Research Associate II
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name: Patty Vasquez
Phone: 949-250-2500
Fax:
Email: patty_vasquez@edwards.com
Salary: d.o.e.
Job Description:
This is a great in-house opportunity within our fast growing Critical Care organization. Be a part
of a high energy team working on cutting edge critical care products with tremendous sales expectations.
The CRA will support clinical study activities to ensure rapid and timely approval of products and/or
support of marketing claims. A CRA is able to work independently on clinical study activities with minimal
supervision.
Responsibilities include:
• Plan, conduct, and monitor clinical studies with minimal supervision. Conduct prestudy, Initiation, Interim
and Closeout monitoring visits at assigned clinical sites, as needed. Prepare site monitor visit confirmation,
site visit reports and follow-up letters.
• Interface with Study Coordinators, Investigators, and IRB's /Ethics Committees, and Edwards' cross-functional
teams. Monitor clinical studies for high level of compliance.
• Prepare clinical sections for inclusion in Clinical Protocols.
• Prepare clinical sections for inclusion in regulatory submissions (e.g., IDE, PMA, 510k) and to support clinical
claims.
• Draft study specific Informed Consent Form (ICF) and review proposed ICF from study sites prior to submission to
IRB's/Ethics Committees.
• Create study specific CRFs.
• Participate in the development of department procedures and best practices.
Job Requirements:
*Multi-level position: Position title and level posted is preferred; however, depending on background and experience,
we will also consider hiring at the Clinical Research Associate I or Sr. Clinical Research Associate levels.
• Hands-on clinical research experience encompassing all aspects of the clinical process is required as follows: A minimum
of six months for the Clinical Research Associate I; a minimum of three years for the Clinical Research Associate II; a
minimum of six years for the Sr. Clinical Research Associate.
• BS/BA/BSN required. Professional certification (e.g., CCRA), and critical care and/or cardiac experience preferred.
Clinical & device industry experience preferred.
• Understanding of Good Clinical Practice (GCP) and basic understanding of clinical trial management required. Demonstrated
understanding of medical terminology.
• The successful candidate will be highly organized, detail-oriented, provide outstanding customer service and have the
ability to work both independently and in a team environment. Must have a positive "can-do" attitude with strong written
and verbal communication skills, analytical thinking and interpersonal skills.
• Preferable candidates with proactive approach to challenges, the ability to work well under pressure and a good sense of
humor.
• Ability to prepare accurate, thorough and complete documents, including monitoring reports required.
Posted: March 20, 2008
Job Title: Clinical Assistant I
Company Name: Spectrum Pharmaceuticals
Location: Irvine, CA
Job Type: Biologics/Biotechnology
Contact Name: Nicole Rogers
Phone: 949-743-9223
Fax: 949-788-6706
Email: nrogers@spectrumpharm.com
Salary:
Job Description:
Summary: Assist clinical development team with administrative activities related to the conduct
of clinical trials; maintains clinical document files and assist CRAs with assuring adherence to
Good Clinical Practices at investigational sites.
Responsibilities:
•Review clinical documents to ensure adherence with the CFRs and company SOPs and procedures.
•Contact sites by phone or via email to request appropriate documentation.
•Assure appropriate filing of essential study-related correspondence, clinical and regulatory site documents.
•Maintain clinical document integrity and security.
•Participate in the review and tracking of clinical documents; i.e., FDA Form 1572, IRB/EC approvals and Informed
Consents, and other assigned clinical projects.
•Perform administrative and clerical duties as assigned.
•Assist CRAs with preparation of site monitoring and follow-up needs.
•Coordinate shipment/distribution of study-related materials and communications to sites.
•Assist CRAs and performs in-house activities to support CRAs who are traveling.
•Serve as liaison between clinical sites and in-house personnel.
•Attend team meetings. Take and distribute minutes to team members.
•Assemble new site start up regulatory document notebooks.
•Assist CRA in preparing materials for study initiation.
•Under close supervision, may assist with the following activities of in-house monitoring:
oGenerate queries to resolve data issues.
oCheck for appropriate DCF resolution and provide follow-up with sites as necessary.
Job Requirements:
•Accuracy and attention to details critical.
•Ability to work with others.
•Takes direction well.
•Organized, able to assess priorities and meet deadlines.
•Accuracy and ability to proofread work.
Posted: March 19, 2008
Job Title: Regulatory Affairs Assistant
Company Name: Spectrum Pharmaceuticals
Location: Irvine, CA
Job Type: Biologics/Biotechnology
Contact Name: Nicole Rogers
Phone: 949-743-9223
Fax: 949-788-6706
Email: nrogers@spectrumpharm.com
Salary:
Job Description:
Summary: Document support for regulatory operations. Prepare the receipt, scanning, indexing
and archival of hard copy and electronic submissions that includes GCP, GLP, GMP, and regulatory
files. Provide support for the creation, editing and version control of complex structured documents.
Responsibilities:
•Create and edit word processing, spreadsheet and presentation files.
•Establish proper filing and version control procedures for Company documents.
•Manage regulatory document control as per GCP, GMP and MP compliance.
•Prepare and scan files using Adobe Acrobat; bookmark and hypertext link file content.
•Assist functional areas and project teams in the preparation and review of documents for regulatory submission.
•Coordinate, organize, index, compile and file quality submissions in accordance with FDA, NIH and ICH guidelines.
•Maintain literature searches, index and archive both paper and electronic documents.
•Liaise with Quality and Regulatory personnel to support projects and submissions as required.
•Keep current on regulations, laws and guidelines.
•Coordinate creation, revisions, formatting and approvals of SOPs, protocols, templates and other GXP documents.
•Assist with other projects as assigned.
Job Requirements:
•Bachelor-level degree and experience in regulated industry.
•Good organizational skills and proficiency with electronic databases.
•Excellent proficiency in WORD and Acrobat
•Experience with the organization and management of controlled documents maintained in accordance with
FDA and ICH requirements.
• Experience with the preparation of complex documents or regulatory submissions is strongly preferred
(e.g., NDA, IND, CTD/eCTD).
•Experience with document control functions, software programs, databases and spreadsheets required.
Experience with electronic documentation systems and computer validation a plus.
Posted: March 19, 2008
Job Title: Director, Regulatory Affairs and Clinical Trials
Company Name: Fortune Executive Recruiting
Location: Los Angeles, CA
Job Type: IVD
Contact Name: Will Martin
Phone: 336-852-4455
Fax:
Email: will@fpcgboro.com
Salary: $135,000
Job Description:
The Director of RA position will be responsible for the regulatory processes involved
with IVD development. Experience with 510(k)'s, IDE's and pre-IDE's a must. This
position offers great growth opportunity, with high visibility to corporate reports.
Diagnostics experience preferred. Must be able to communicate effectively to scientists
and non-scientists alike. International regulatory experience a plus.
Job Requirements:
B.S. in Immunology, Microbiology, Biology or related field a must, M.S. or PhD preferred.
Supervisory experience preferred, with a minimum of 5 years regulatory experience in a
FDA-regulated environment. RAC certification preferred.
Posted: March 17, 2008
Job Title: Quality Engineer
Company Name: USGI Medical Inc.
Location: San Clemente, CA
Job Type: Devices
Contact Name: Amy Boucly
Phone: 949-369-3890 X1217
Fax: 949-369-3891
Email: aboucly@usgimedical.com
Salary:
Job Description:
Duties and Responsibilities:
•Responsible for formulating inspection instructions, equipment and gage requirements
and sampling plans for receiving, in-process and final inspection.
•Provide daily hands-on QE support to Manufacturing floor.
•Provide information and QE support for ongoing product design and new product design review
boards; participate in risk analysis, design input and change review.
•Formulate and execute product and process validation protocols and write reports.
•Use statistical tools to analyze data, make acceptance decisions and improve process capability
(Six Sigma, SPC, DOE).
•Routinely trend quality indictors and issue reports to USGI management.
•Monitor and ensure compliance with sterilization requirements and procedures (gamma/EO).
•Participate in MRB, complaint analysis, root cause investigation and corrective/preventive action.
•Participate in supplier selection and qualification. Monitor/trend supplier performance and resolve
nonconformances so as to prevent recurrence.
•Perform internal and supplier audits. Requires occasional travel.
•Ensure company compliance with the company’s Quality Policy and procedures, the Quality System
Regulation and ISO 13485:2003.
•Participate in FDA and State inspections and Notified Body surveillance audits.
Job Requirements:
Minimum Requirements:
•BS degree in a related engineering discipline preferred; CQE preferred.
•Minimum three years experience as a Quality Engineer in the medical device industry. Medical device start-up
experience is a plus.
•Thorough knowledge of Quality and Operations systems and processes, including GMP and QSR requirements.
•Familiarity with product development life cycle, manufacturing processes and equipment, test methods, inspection
techniques, validation studies and product and process validation.
•Ability to utilize equipment such as calipers, microscopes, pin gages, vision system and other measuring equipment.
•Proficient in use of statistical tools.
•Detail-oriented.
•Excellent written and verbal communication and problem-solving skills.
•Proven interpersonal and organizational skills.
•Highly motivated, enthusiastic, strong work ethic.
•Creative problem solver with ability to work in team environment.
We offer a can-do work environment and a competitive salary and benefits package, including stock options to all regular,
full-time employees.
Posted: March 14, 2008
Job Title: Manager, Regulatory and Clinical Affairs
Company Name: Cardiogenesis Corporation
Location: Irvine, CA
Job Type: Devices
Contact Name: Ed Musolff
Phone: 949-420-1802
Fax: 949-420-1873
Email: emusolff@cardiogenesis.com
Salary:
Job Description:
The Manager, Regulatory and Clinical Affairs (RAC) is responsible for the RAC plan including
all essential clinical research programs and activities and regulatory affairs activities in
support of the operating plan.
Responsibilities:
* Manage all clinical research programs and activities
* Perform all essential regulatory affairs activities
* Establish and maintain a current RAC plan in support of the operating plan
* Provide the RAC plan including budget for review and approval by management team
* Recruit, hire and develop the essential RAC resources to execute the plan in support of the operating plan
* Establish and maintain detailed RAC plans and provide frequent status updates to the management team
* Ensure RAC activities are coordinated with sales and marketing to contribute to positive customer relationships
and program success
* Provide technical writing skills in support of clinical research protocol development and regulatory submissions
Job Requirements:
* At least five years medical device clinical & regulatory affairs experience
* Bachelors Degree in science/technical field required
* Travel required
Posted: March 12, 2008
Job Title: Senior Quality Engineer (0801994)
Company Name: Johnson & Johnson
Location: Irwindale, CA
Job Type: Biologics/Biotechnology
Contact Name:
Phone:
Fax:
Email: khenslee@corus.jnj.com
Salary:
Job Description:
Key areas of responsibility
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a
Senior Quality Engineer, located in Irwindale, CA. The Senior Quality Engineer will participate in new
product/process teams to develop quality-engineered systems and products, and to ensure compliance with the
company’s Quality System policies and procedures and applicable external requirements and standards, including
FDA, ISO 13485, Johnson & Johnson Environmental Practices, and applicable EN, IEC, and AAMI standards as
pertains to medical devices. Use statistical tools to analyze data, make acceptance decisions, and improve
process capability (Six Sigma, SPC, DOE). Direct Failure Mode and Effects Analysis activities for both Design
and Process FMEA’s. . Determine sterility, biological and packaging test requirements utilizing appropriate
industry or agency standards for new products. Ensure that development activities follow design control requirements,
product is tested per applicable standards, European Essential Requirements are met per the MDD, and product is
properly transferred to manufacturing. Provide all planning necessary to ensure effective product acceptance. The QE
will inspection instructions, equipment and gage requirements, and sampling plans. Perform vendor audits and participate
in supplier selection as necessary. Participate in MRB review of nonconforming product; recommend disposition and corrective action.
Job Requirements:
BS in a related engineering discipline with at least 5 or more years of related experience or MS in a related engineering
discipline and 3 or more years of related experience are required. Prior quality engineering, and/or manufacturing engineering
and/or product development experience in the medical device, pharmaceutical or biotech industry are highly desirable. It’s
required that previous experience should include familiarity with product development life cycle, manufacturing processes and
equipment, test methods, inspection techniques, validation studies and product and process validation. Hands on experience with
design control and design of experiments is required. Ability to develop and implement Quality standards is required. Thorough
knowledge of Quality and operations systems and processes, including GMP and QSR requirements are required. Command of Six Sigma
and Process Excellence tools and methodologies or CQE preferred. Demonstrated verbal and written communi cation skills, and
ability to effectively communicate with internal and external personnel.
Posted: March 8, 2008
Job Title: Regulatory Assistant
Company Name: Oasis Medical, Inc.
Location: Glendora, CA
Job Type: Devices, Drugs, Biologics/Biotechnology
Contact Name: Robyn Scopis
Phone: 626-852-5156
Fax: 626-914-9372
Email: robyn@oasismedical.com
Salary: Variable upon experience
Job Description:
Key areas of responsibility
•Provide project, department, and company guidance and training based on current and emerging
regulatory affairs requirements, regulations, and processes, and focus on improved regulatory
efficiency and effectiveness.
•Involvement in ongoing administrative tasks in support of the Regulatory department.
•Maintain submission correspondence files and other regulatory files in a complete and secure manner.
•Maintain annual facility registration and device-listing documents.
•Ensure that existing approvals and documentation are maintained.
•Conduct regulatory research with location and analysis of regulations, including international regulations.
•Monitor and research changes in the regulatory and competitive environment, evaluate impact, and communicate
to interested parties.
•Attend industry trade shows and training courses to stay current on regulation issues.
•Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance.
•Responsible for foreign registrations and export documents.
Job Requirements:
Basic Qualifications
•An undergraduate degree with 2-4 years experience or an Associate degree with 4-6 years experience.
•Understanding of:
oFDA medical device regulations, guidance, and import/exports requirements.
oMedical device quality systems.
oProduct development processes.
oAwareness of international regulatory requirements and systems.
•Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, database, graphics presentation
applications, document processing/publishing tools.
•Detail oriented.
•Self-motivated.
•Excellent time management skills.
•Ability to work under minimal supervision and independently.
•Must be able to handle multiple assignments concurrently, capacity to produce high quality results across
multiple projects while working under pressure of short deadlines.
•Understanding of business processes, knowledge of GMP’s and the fundamentals of auditing.
Posted: March 8, 2008
Job Title: Senior Safety Clinical Research Associate
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name:
Phone:
Fax:
Email:
Salary:
Job Description:
Exciting opportunity within the world leader in Heart Valves to advance patient care through
clinical research on our Trans Catheter Heart Valve Program.
Process adverse device experiences (ADEs) from clinical trials including accurate data entry in
the clinical trial database, and regulatory reporting. Track and process adverse device experiences
(ADEs) from clinical trial sites. Collect source documents on all serious adverse events (SAEs)
from clinical trial sites. Check for accurate data entry in the clinical trial database, and
communicates with appropriate individuals to obtain initial and follow-up adverse event information.
Determine regulatory reporting requirements based on serious criteria, causality and whether event is
anticipated per clinical protocol/IB. Prepare adverse event reports for regulatory submission in
compliance with worldwide reporting requirements including individual expedited case reports such as
UADEs, aggregate reports and other regulatory documents as requested. Interact with DSMB and CEC for
the purposes of safety data collection, data reconciliation, etc. Understand applicable corporate and
global regulations, guidelines, SOPs and writing practices.
Job Requirements:
• A minimum of five years previous research or clinical hospital experience required.
• Previous experience in drug or device safety reporting highly desirable.
• Bachelors degree in a science-related field, nursing or equivalent required.
• Must have understanding of medical terminology and familiarity with principles of clinical assessment of ADEs.
• Knowledge of global regulations and guidelines is desirable.
• Basic understanding of computer technology.
• Ability to work under supervision in a matrix organization.
• Good oral and written communication skills.
To apply directly to this position, please cut and paste this link into your browser:
http://www.edwards.com/Careers/reqfinder?urlvariablestring=2647
Posted: March 7, 2008
Back to List
Job Title: Global Regulatory Affairs Director
Company Name: Pharmaceutical Services Corporation
Location: Pomona, CA
Job Type: Devices, Devices, Drugs, IVD, Biologics/Biotechnology
Contact Name: Susan
Phone: 909.784.3350
Fax:
Email: sma@biotech.com
Salary:DOE
Job Description:
To Apply:
https://www.psccareers.com/can/applyonline.php?id=14
Pharmaceutical Services Corporation is looking for an experienced and forward-thinking
individual to manage and lead the Company's internal teams and external clients in all
aspects of regulatory affairs. We are currently considering candidates in North America,
Europe, Asia and the Middle East. The successful candidate will be responsible for
regulatory activities related to IND, NDA, ANDA, NDS, MAA, BLA submissions and related
amendments, and key interactions with regulatory authorities and agencies. Knowledge of
current FDA, EMEA, WHO and ICH regulatory requirements and guidelines is essential. The
scope of responsibility spans all global registration efforts including North America,
Europe, Asia and the Middle East.
Job Requirements:
- Act as or manage FDA liaison and liaison to Ex-US Health Authorities. Responsible for the
preparation for key meetings with the FDA and other regulatory authorities.
- Prepare FDA and international submissions including IND, CTA, ANDA/NDA/CTD, SNDAs, IMPD,
NDS, MAA, BLA amendments, supplements, variations, responses to Agency questions, meeting
requests, briefing packages, annual reports, and periodic safety reports, etc.
- Develop and implement policies and procedures to ensure compliance with FDA and other
international regulatory agency rules as required.
- Participate in clinical regulatory strategic planning. Assist with preparation of clinical
trial documentation such as Investigator's Brochures, protocols/amendments, and related reports,
presentations, and press releases, etc.
- Provide regulatory input and guidance on product pre- and post launch activities, including
new indications and claims (e.g. clinical trial protocols, filing requirements, labeling, and
promotional items).
- Act as regulatory representative on Product Development Teams.
- Budget planning and management.
- Project timeline planning and management including recruiting as required.
Minimum of BS degree + 10 yrs exp or MS degree + 7 yrs exp in regulatory affairs. Solid Oral Dosage
and/or sterile injectable experience preferred.
Posted: March 5, 2008
Back to List
Job Title: Director, Global Quality Systems
Company Name: Confidential
Location: Indiana
Job Type: Devices
Contact Name: Cheryl Jones
Phone: 818-552-2036 ext. 412
Fax:
Email: recruit@medexecintl.com
Salary:Industry Competitive
Job Description:
Location: Indiana
Job Summary:
Responsible for providing strategic direction and oversight in the development and
implementation of Global Quality System. Provides leadership for the company’s Global
Quality System, Regulatory Education and Training, Process Validation, and Document
control programs.
General Functions:
• Ensure Global quality system development and implementation
• Develop global quality system programs to leverage systems among all sites
• Create and communicate a high commitment to quality and customer service
• Develop relationships with quality, regulatory and governmental affairs organizations and agencies
• Utilize available resources to drive the decision-making process involving Quality Systems
• Coordinate validation activities
• Periodically reviews regulatory agency requirements
• Succession planning
Job Requirements:
• Bachelor’s degree in relevant field (e.g., engineering, materials science or life science);
Master’s degree is preferred
• 8-10 years experience in a Quality-related area
• Quality assurance and quality systems experience
• Medical device operations experience including manufacturing, QC/QA and R&D
• Experienced in advanced technology including technology transfer
• Extensive knowledge of GMP regulations
• Experience with FDA regulations & Regulatory Bodies
• CQE/CQA preferred
• Travel Requirements – 10 to 20 percent
Posted: March 4, 2008
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Job Title: Director, QA/RA
Company Name: Integra OrthoBiologics
Location: Irvine, CA
Job Type: Biologics/Biotechnology
Contact Name:
Phone: 949-595-8703
Fax:
Email: hr@isotis.com
Salary:
Job Description:
Provide leadership for compliance with quality and regulatory standards, ensuring that
company-wide activities are performed in compliance with applicable standards and regulations.
Ensures customer and regulatory requirements are established and met. Act as a liaison between the
company and regulatory authorities for domestic and international regulatory application files.
Functions as the Management Representative for the Quality System.
• Oversee the preparation and submission of regulatory applications (i.e. 501(k), IDE, PMA, Technical
Files, Human Tissue product applications).
• Manage and oversee the requirements of the company for compliance with FDA, AATB, State Tissue Bank,
and International regulations regarding human tissue based products.
• Provide guidance and interpretation of quality and regulatory issues for product development teams,
assuring that design and development requirements are met; recommend, and implement compliance strategies
for existing, new, and proposed products.
• Monitor/review internal/external audit noncompliance’s and act as Quality liaison in ensuring that all
other departments meet their respective quality system standards, ensure that corrective actions identified
through the process of audit or investigation are adequately validated, implemented and are effective.
• Serve as primary compliance interface for inspections by FDA, ISO, AATB, State Tissue Bank agencies and
all other regulatory/certification agencies.
Job R