Job Title: Senior Clinical Compliance Associate
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name: Patty Vasquez
Phone: 
Fax: 
Email: Patty_Vasquez@edwards.com
Salary: 

Job Description:

Responsible for performing a wide variety of activities pertaining to assuring compliance with global operating procedures and regulatory requirements for Clinical Operations.
Will assist in SOP development, maintaining and training, as well as templates, forms and other study related documents for Clinical Operations.

Key responsibilities:

•Develop work plans and schedules for compliance monitoring of multiple concurrent clinical study projects with progressively less oversight.
•Deliver completed compliance monitoring reports within established time frames and standards.
•Participate in departmental and/or corporate quality initiatives.
•Maintain a working knowledge of current and proposed laws, regulations and guidelines.
•Support the management of internal and external compliance monitoring of Edwards Lifesciences operations.
•Provide guidance to Edwards Lifesciences facilities regarding regulatory compliance and internal policies and procedures.
•Review and provide feedback on clinical protocols, CRFs, Clinical Study Reports and other clinical documents.
•Conduct compliance monitoring visits for clinical study sites
•Assist in compliance monitoring training and clinical affairs training
•Oversee compliance with establishment registrations

Job Requirements:

The Clinical Compliance Associate III level requires a minimum of four years related work experience within the medical device industry or other regulated industry; and the Senior Associate, Clinical Compliance level requires a minimum of five years experience within the medical device industry or other regulated industry. Prior work experience in Clinical Monitoring, Quality Assurance/Control or Regulatory Compliance is required. Experience with site monitoring is a plus.

A Bachelors degree is required, preferably in a scientific or related discipline.

Knowledgeable on diverse regulations and standards such as: 21 CFR Part 11/50/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICHs, and other applicable regulations.

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=3544

Posted: July 2, 2009

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Job Title: Regulatory Compliance Auditor
Company Name: Grifols Biologicals
Location: Los Angeles, CA
Job Type: Drugs, Biologics/Biotechnology
Contact Name: Kerry Clark
Phone: 
Fax: 
Email: Kerry.Clark@grifols.com
Salary: Depends on Experience

Job Description:

Grifols manufactures plasma derived biopharmaceutical products. We have an immediate opening for an Auditor in our Regulatory Compliance department offering competitive salary, along with excellent benefits. For more information, please visit our website: http://www.grifolsusa.com/.

Summary:

• This position includes the following areas of responsibility:
Conduct internal cGMP audits, as well as supplier audits.
Write audit and summary reports.
Participate in the audit response and corrective action process.
Verify implementation of corrective actions.
Write and revise documents and procedures.
Conduct training on procedures, cGMPs , and industry standards.
Give presentations.
Participate in customer audits, third party audits and national or international regulatory agency audits.

Responsibilities:

•Coordinate and schedule and/or perform internal cGMP and GLP compliance audits of the manufacturing, QC testing, and warehouse facilities.
•Coordinate and schedule and /or perform cGMP and GLP compliance audits of company’s suppliers and contract laboratories. Assist in the activities associated with regulatory inspections.
•Coordinate and participate in audit activities associated with company’s customers.
•Participate in the development, coordination and presentation of training programs within the areas of responsibility for the department.
•Writes and revises documents and procedures relevant to the auditing function.
•Issues audit reports, assist in the audit responses, verify the implementation and evaluate the appropriateness of corrective actions.

Job Requirements:

Skills/Qualifications:
•Minimum four years of experience in Regulatory Compliance, Regulatory affairs, Quality Engineering, Quality Control or Quality Assurance conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers.
•Experience in the Pharmaceutical, Biologics, or Medical Device industry is required.
•A minimum of a Bachelor Degree in one of the Life Sciences, or Engineering Bachelor Degree.
•Certification in industry auditor training programs, such as (ASQ, RAPS, ISO etc.) is mandatory.
•Working knowledge and understanding of concepts of cGMP and GLP.
•Understanding of industry standard operational/manufacturing practices.
•Knowledge of US and international regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products.
•Good verbal, written communication and negotiations skills.
•Computer literacy with proficiency in MS Word, Access, and knowledge of Excel and PowerPoint.
•Able to work independently with minimal supervision.
•Well developed communication skills especially in stand-up presentation or facilitation.
•Willing to travel as needed, domestically and internationally, with overnight stays from one to two days to up to two weeks.
•Good leadership and interpersonal skills, with the ability to direct the work of others.
•Able to adhere to Manufacturing and QC Laboratory gowning and safety procedural requirements. This position requires frequent gowning in-order to support audit activities in the environmentally controlled facilities during internal audits, customer audits, regulatory audits and supplier audits.

To submit your resume for consideration, please email Kerry.Clark@grifols.com with a subject line of "Auditor".

Posted: June 16, 2009

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Job Title: VP, Clinical and Regulatory Affairs
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type: Devices
Contact Name: Patty Vasquez
Phone: 
Fax: 
Email: Patty_Vasquez@edwards.com
Salary: 

Job Description:

Overall objective is to lead the development and execution of Edwards' Global Regulatory Affairs programs for Critical Care business unit.

• Develop strategy for critical product approvals globally and intervene to address substantial implementation challenges
• Lead the development and execution of clinical research for the Critical Care group
• Responsible for driving our Regulatory Affairs/Clinical Affairs programs to the next level by developing and staffing world class team
• Key member of Critical Care Leadership team, responsible to drive strategic decision making base on Regulatory Affairs and Clinical Affairs strategy
• Leverage stature and experience within the global medical device regulatory community, policy makers, and FDA

Job Requirements:

Established senior level regulatory affairs leader, with a minimum of 15 years of experience in Medical Device Regulatory Affairs, to include leadership of a significant clinical trial.  Must have experience leading Regulatory Affairs and Clinical Affairs programs with class III medical devices.  Prior experience to include: effective management, staffing and training of regulatory and clinical affairs functions.

Must have a well recognized stature within the Medical Device RA community.

Must have a history of positive interactions with FDA and other regulatory authorities and extensive knowledge of global regulatory and clinical requirements for cardiovascular medical devices.

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:
http://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=3522

Posted: June 6, 2009

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Job Title: Senior Microbiologist
Company Name: ATS Medical, Inc.
Location: Lake Forest, CA
Job Type: Devices
Contact Name: Human Resources
Phone: 763-553-7736
Fax: 763-557-2244
Email: human.resources@atsmedical.com
Salary: DOE

Job Description:

ATS Medical, a leading provider of lifesaving cardiac surgery products and services has an opening for a Sr. Microbiologist in its Lake Forest, CA facility. This position is responsible for routine microbiology activities (e.g. sterility, sterilization validation, bioburden, environmental monitoring, LAL) including the investigation and resolution of OOS results.

Job Requirements:

BS in Microbiology or Life Science with a minimum 3 years experience in an FDA regulated industry. Requires effective written and oral communication; interpersonal skills to work effectively with others at all levels, both within and outside of the organization; and good technical, analytical and organizational skills.  Quality Auditing certificate, training and/or related experience is a plus.

Posted: June 6, 2009

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Job Title: Regulatory Submission Associate
Company Name: Class III - medical device company
Location: San Clemente, CA
Job Type: Devices
Contact Name: Jose Javier
Phone: 949-271-6364
Fax: 
Email: jose.javier@sanlink.net
Salary: market rate and competitive DOE

Job Description:

-    Responsible for the planning, preparation and review process for regulatory submissions to the FDA and other worldwide government agencies. -     Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
-     Interacts with regulatory agencies and Notified Body as required in support of regulatory submissions.
-    Perform regulatory review of engineering change orders for regulatory reporting and prior approval determinations.  Ensures adequacy of ECO documents and associated source documents to support regulatory filings.  Prepares notifications and supplements to regulatory submissions for changes.
-     Perform regulatory review of labeling and advertising to ensure compliance to pertinent regulations and that claims are supported by appropriate data.
-     Serve as RA Representative on development project teams.
-     Performs regulatory review for technical protocols and reports.
-     Researches and documents regulatory strategies for new products.
-     Fulfills selected Quality System requirements as described within the Corporation Quality Systems Manual (specifically related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).
-     Assist the documentation staff, as needed, with the archiving, tracking, and maintenance of electronic and paper Regulatory files and with the establishment, data entry, and maintenance of the regulatory electronic databases.

Job Requirements:

- B.S. degree in life sciences or related field. - Minimum of 3 years experience in the medical device regulatory field.  Class III device experience preferred.
-     Highly knowledgeable in worldwide regulatory requirements (e.g. FDA regulations 21 CFR 50, 54, 801, 803, 812, 814, 820, 821; AIMD 90/385/EEC; MDD 93/42/EEC).
-     Must demonstrate a proven track record in obtaining FDA clearances and worldwide registrations.
-     Should possess strong verbal and written communication skills.
-  Ability to work independently, and/or within a team environment and cross functionally with other departments.
-     Demonstrated ability to coordinate projects.
-     Very good analytical and problem solving skills.
-     Word processing skills, including Microsoft Word, Excel, Access or comparable software.

Posted: June 6, 2009

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Job Title: Quality Engineer
Company Name: Quantimetrix Corporation
Location: Redondo Beach, CA
Job Type: Devices, IVD, Biologics
Contact Name: 
Phone: 
Fax: 310-267-3636
Email: hr@4qc.com
Salary: 

Job Description:

For over 30 years, Quantimetrix has been developing and manufacturing innovative clinical laboratory quality control products with the customer in mind. Each Quantimetrix employee is empowered to improve our processes through their exceptional work.  We are currently recruiting for a full-time Quality Engineer.

MAJOR DUTIES AND RESPONSIBILITIES:
•   Provides focused hands-on quality engineering support to R&D,Manufacturing and Quality Control for existing and new product quality issues and continually seeks to drive improvements in product and process quality.
•    Conducts FMEA, raw material characterization, risk management and equipment method validations.
•   Utilizes standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process capabilities and assist R&D in Design Control and process transfer to Manufacturing.
•    Participates in design reviews for new product development and design/process changes.
•    Prepares Validation protocols and / or executes protocols.
•    Prepares SOPs and inspection/test methods and other change control related documentation.
•    Prepares Master Validation Plans and participates in process qualifications.
•    Responsible for ensuring all quality standards and specification are defined and achieved in line with appropriate regulatory requirements, especially the FDA Quality System Regulation and ISO 13485:2003.
•    Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
•    Perform other tasks and duties as directed by the Director of Quality Assurance and Regulatory Affairs.
•    Assist in maintaining Quantimetrix Corporation quality system.

Job Requirements:

QUALIFICATIONS:  Education: B.S. in related fields or equivalent, science or Engineering preferred.  Minimum of 5+ years experience as a Quality engineer in a medical device / in vitro diagnostic manufacturing environment, with a minimum of 1 year as a lead or senior quality engineer. Strong knowledge and hands-on experience in the application and implementation of (GMP/QSR/ISO/MDD).

In return for your hard work and dedication, we offer a competitive compensation and benefits package that includes medical, vision, dental, life insurance, matching 401(k) plan, PTO and other great benefits.  For more information about us, please visit our website:  http://www.4qc.com.  Then send your resume with salary history to hr@4qc.com.

EOE

Posted: June 6, 2009

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Job Title: Senior Regulatory Affairs Specialist
Company Name: ev3, Neurovascular, Inc.
Location: Irvine, CA
Job Type: Devices
Contact Name: Karthryn Henslee
Phone: 714-865-9284
Fax: 
Email: kathrynhenslee@att.net
Salary: DOE

Job Description:

ev3, Neurovascular is currently seeking a Senior Regulatory Affairs Specialist to be located at our manufacturing facility in Irvine, CA.
At ev3, we're committed to developing innovative endovascular technologies for coronary, peripheral and neurological applications.  Creative, competent people with a passion for enhancing healthcare around the globe have driven our success.  Join us as we grow by making a meaningful difference!
This Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States, Europe, Japan, Canada, and markets within Asia, Latin America, Central Europe, and the Middle East.  This Senior Regulatory Affairs Specialist is also responsible for the regulatory review of design changes, manufacturing changes and specification changes.
POSITION SUMMARY
Ensurecompliance with relevant FDA, MDD, ISO and other global regulations, for ev3 peripheral vascular products.  Participate on internal development teams, providing US and/or International regulatory strategy and execution.  Ability to lead and execute complex regulatory projects.  Regulatory review of labeling and advertising, design changes, and specification changes.

Job Requirements:

Bachelor’s degree in related field with at least 5 years of US and International medical device regulatory submission/approval experience, to include FDA, EU, MDD, MHLW, TGA, and TPP requirements. Must have experience with 510(k) and IDE. Experience with PMA is highly desired. Regulatory Affairs Certification (desired)
We offer competitive compensation, generous benefits, and the opportunity to improve the lives of people everywhere
\
Posted: May 20, 2009

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Job Title: Compliance Specialist
Company Name: Trimedyne, Inc.
Location: Lake Forest, CA
Job Type: Devices
Contact Name: Mary Isun
Phone: 949-951-3800 x290
Fax: 949-855-3764
Email: misun@trimedyne.com
Salary: DOE

Job Description:

In this position, you will be responsible for completing a wide variety of assignments under general supervision within the scope of medical device compliance/regulatory affairs.  These assignments are part of the process of maintaining corporate regulatory compliance with domestic and international regulations, standards, and policies and will include:
•Perform various functions regarding customer complaints
•Prepare and submit adverse event reports (MDR, MDVS, CMDR, etc.) and initial and/or updated product baseline reports
•CAPA/PA system administration
•Compile and prepare information for various summary reports, including complaint trending and NCR summaries
•Assist in coordinating, documenting and conducting internal quality audits
•Assist in review and approval of change management materials as required
•Assist in planning, coordinating and executing various aspects of the Company’s quality program
•Perform trending and provide reports related to the effectiveness of the quality program
•Work with the product development and manufacturing departments as a team to find solutions and/or develop new approaches to solve problems identified during quality activities
•Perform quality related training as needed
•Perform reviews of device history records
•Assist in third party audits of the Company’s quality system activities
•Assist during regulatory corrective actions such as recalls

Job Requirements:

Qualified candidates will meet the following requirements:
•Excellent verbal and written communication skills
•Excellent organizational and interpersonal skills
•Excellent follow through skills and attention to detail
•Strong working knowledge of computer software (word processing, spreadsheets, databases, etc.) and ability to use spreadsheets for inputting, organizing/sorting, graphing, linking and presentation of data to meet a variety of needs.  Advanced working knowledge of spreadsheets is a must.
•Ability to work efficiently and effectively in a fast paced environment.
•Minimum of Associate’s Degree (Bachelor’s Degree preferred)
•Two to five years experience in a regulatory compliance function, preferably in the medical device industry.

Posted: May 19, 2009

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Job Title: Project Manager - Regulatory Affairs
Company Name: SkinGenix, Inc.
Location: Arcadia, CA
Job Type: Devices, Drugs
Contact Name: 
Phone: 
Fax: 
Email: hr@skingenix.us
Salary: 

Job Description:

SkinGenix is initiating two pilot Phase II clinical studies in southern California for MEBO’s wound ointment product that can invigorate adult skin stem cells for in situ skin regeneration and heal deep partial thickness burns and chronic wounds in improved scar quality. This product has been approved in China since 1988 and marketed in twenty-four countries outside US. It is a very reputable first-in-the-class product that US Newsweek regarded its achievement as a new approach changing the world’s burn treatment.

SkinGenix has an immediate opening for a full time, permanent regulatory position. As a Project Manager in Regulatory, you will be responsible or IND submissions and lifecycle managements, FDA correspondences, and regulatory documentation administrations. Minimal national and international traveling are required.

As a key employee, you will enjoy the opportunity to be involved in every aspects of medical product development process and to contribute in SkinGenix’s worldwide business development adventures.

Job Requirements:

1.    Bachelor degree required. Master degree desired. 
2.    RAC, CCRP, or CRA certification required.
3.    Minimum 5-year regulatory working experience and comprehensive knowledge of eCTD submission required.
4.    Excellent oral and written communication skills.
5.    Self-motivated, organized, and detail oriented.
6.    Reputable employment history.

Posted: May 4, 2009

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Job Title: Project Manager - Clinical Trials Management
Company Name: SkinGenix, Inc.
Location: Arcadua, CA
Job Type: Devices, Drugs
Contact Name: 
Phone: 
Fax: 
Email: hr@skingenix.us
Salary: 

Job Description:

SkinGenix is initiating two pilot Phase II clinical studies in southern California for MEBO’s wound ointment product that can invigorate adult skin stem cells for in situ skin regeneration and heal deep partial thickness burns and chronic wounds in improved scar quality. This product has been approved in China since 1988 and marketed in twenty-four countries outside US. It is a very reputable first-in-the-class product that US Newsweek regarded its achievement as a new approach changing the world’s burn treatment.

SkinGenix has an immediate opening for a full time, permanent clinical trial management position. As a Project Manager, you will be responsible for project planning and management, clinical trial monitoring, and assisting in IND lifecycle management and FDA correspondences. Minimal national and international traveling are required.

As a key employee, you will enjoy the opportunity to be involved in every aspects of medical product development process and to contribute in SkinGenix’s worldwide business development adventures.

Job Requirements:

1.    Bachelor degree required. Master degree desired. 
2.    CCRP, CRA, CRC, or RAC certification required.
3.    Minimum 5-year monitoring and/or medical product development working experience required. Comprehensive knowledge of eCTD preferred.
4.    Excellent oral and written communication skills.
5.    Self-motivated, organized, and detail oriented.
6.    Reputable employment history.

Posted: May 4, 2009

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Job Title: Senior Director/VP Clinical Affairs
Company Name: Publicly Traded IVD Company
Location: San Diego, CA
Job Type: IVD
Contact Name: Julia Kaplan
Phone: 858-229-7300
Fax: 
Email: jkaplan@juliakaplan.com
Salary: 

Job Description:

The position will have 35+ reports (clinical affairs, medical writing, biostatics) and reports to the Senior Vice President, Clinical, Regulatory and Quality.   The ideal candidate will have extensive experience in designing, planning, and executing clinical trials for FDA product submissions in accordance with GCP.  Experience with both CBER and CDRH regulated clinical trials is preferred. 

Posted: May 3, 2009

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Job Title: Document Control Specialist
Company Name: 220 Laboratories
Location: Riverside, CA
Job Type: Drugs
Contact Name: Eric Fishman
Phone: 951-683-2912
Fax: 951-683-0952
Email: efishman@220labs.com
Salary: DOE

Job Description:

220 Laboratories is a cosmetics manufacturer which produces a wide range of products including OTC drug finished products. The Document Control Specialist will primarily work on generating Ingredient Lists,MSDS's, and Product Specification Sheets. The position also includes working with raw material vendors to recieve and organize documents pertaining to their products.

Job Requirements:

At least 2-3 years experience of preparing Ingredient Lists and MSDS's is required. Experience in the cosmetics industry is preferred, but experience with the aforementioned documents from other industries will be considered.

Posted: April 29, 2009

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Job Title: Sr. Manager, Regulatory Operations
Company Name: Cougar Biotechnology
Location: Los Angeles, CA
Job Type: Drugs
Contact Name: 
Phone: 
Fax: 
Email: recruiting@cougarbiotechnology.com
Salary: 

Job Description:

The Senior Manager, Regulatory Operations represents Regulatory Operations on regulatory project teams, serves as a primary contact to the FDA and other regulatory authorities related to regulatory submissions, and is primarily responsible for managing project deliverables and resources to meet Regulatory Affairs departmental goals. This position supports submission of Regulatory documents including the planning, scheduling and coordinating of Regulatory submissions and Safety reporting developments, based upon thorough knowledge of applicable regulations for electronic submissions and company procedures.

Job Requirements:

The successful candidate will have a Bachelors degree in a scientific discipline, systems technology or equivalent; knowledge of US and Global requirements with regard to submission content and format; proficiency in the use of Adobe Professional and specialty document publishing tools; and advanced eCTD publishing experience. In addition, the candidate must posses three (3) to five (5) years of drug development/regulatory experience. Knowledge in the compliant use of an enterprise-wide EDMS and managing teams of 2 or more is preferred.

We are not accepting resumes from recruiters at this time; candidates only. Thank you.

Posted: April 29, 2009

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Job Title: Regulatory Affairs Specialist
Company Name: Confidential
Location: Allentown, PA
Job Type: Drugs
Contact Name: Cheryl Jones
Phone: 818-552-3673
Fax: 
Email: cjones@medexecintl.com
Salary: 

Job Description:

This position will originate appropriate documents to obtain and maintain clinical and/or marketing privileges consistent with applicable government requirements.

Responsibilities:
•    Practice Quality System Manual procedures and comply with its requirements
•    Carry out responsibilities as outlined in safety, health and environmental policies
•    Review labeling for compliance with regulations and assure that claims are substantiated
•    Maintain current knowledge base on existing and emerging regulations, standards and guidance document
•    Provide written regulatory strategies for new product ideas
•    Assist in reviewing new projects to determine the nature and scope of the regulatory involvement
•    Answer questions regarding the various elements of CTA for established clients
•    Provide written regulatory strategies for new product and service ideas
•    “Hand-hold” virtual companies through the EU CTA or even complete on their behalf if given the relevant contacts
•    Maintain CTAs where there are expiry date issues that can differ from country to country in the EU
•    Prepare QP declarations, maintain/monitor the QP declaration documentation and interact with client/CRO regulatory affairs
•    Oversee distribution activities (e.g. import and export of IP across borders)

Job Requirements:

•    BA/BS in technical field or scientific discipline
•    Six to eight years minimum clinical supply industry experience
•    Two years project management experience
•    Two years or less development, interpretation or application experience with standards, guidelines and special controls
•    Experience reviewing promotional materials, labeling, and other documentation to assure regulatory compliance
•    Strong working knowledge and application of FDA regulations and requirements with the ability to integrate into projects

Posted: April 28, 2009

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Job Title: Quality Assurance Manager
Company Name: NAMSA
Location: Irvine, CA
Job Type: 
Contact Name: 
Phone: 
Fax: 
Email: hr@namsa.com
Salary: 

Job Description:

NAMSA, the world leader in medical device testing has an immediate opening for a Quality Assurance Manager. Responsibilities will include oversight of the GLP/GMP quality assurance function for a single location, including staffing, budgeting, and training. The Quality Assurance Manager serves as the management representative for ISO 13485 and Quality System Regulation (QSR) and is the primary interface for regulatory agencies for regulatory audits and submissions, and responsible for hosting client audits.

Job Requirements:

This position requires 5 years related work experience, including 2 years management and a Bachelor's degree in a scientific discipline. Must have a working knowledge of 21 CFR 211, 21 CFR 820, 21 CFR 58, and ISO 13485; knowledge of ISO 17025 is preferred.

Posted: April 21, 2009

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Job Title: Director Regulatory Affairs and Corporate Compliance
Company Name: Heidelberg Engineering
Location: Vista, CA
Job Type: Devices
Contact Name: Alda Jorgenson
Phone: 760-720-7340
Fax: 
Email: aldajorg@yahoo.com
Salary: Open

Job Description:

HEIDELBERG ENGINEERING
MANAGER/DIRECTOR REGULATORY AFFAIRS AND CORPORATE COMPLIANCE
LOCATION: VISTA, CA or HEIDELBERG, GERMANY.

Heidelberg Engineering is a leading developer of laser scanning and imaging devices for identifying and tracking eye disease.   We have been a pioneer in developing new analytical approaches for detecting and managing glaucoma as well as diseases of the retina and cornea.  The company’s core technologies include confocal microscopy, scanning lasers and optics, optical coherence tomography and software image analysis.  Our company places a strong emphasis on people, products, and process to continue driving our success.

We are searching for a Manager/Director Regulatory Affairs and Corporate Compliance. This person will be responsible for regulatory submissions to FDA and international agencies for medical device clearance, approval and/or licensing as well as for clinical studies related to device.  This position will work closely with others to prepare submissions for new products and product changes as required to ensure timely approval for market release and interface with multiple functional areas, geographies and divisions within the company.  This position will serve as the Corporate Compliance Officer.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Prepares reviews and submits necessary regulatory information to FDA to obtain 510(k)clearance and PMA approval of products.
•Coordinates with functional areas in the preparation, review and submission of IDE applications for clinical studies, and other clinical studies including marketing studies.
•Reviews all submissions to FDA and international agencies.
•Serves as the primary contact to FDA.
•Keeps up-to-date on proposed regulations and guidelines published by FDA and international agencies.

Job Requirements:

•BS/BA in scientific or engineering discipline/equivalent combination of education and experience. MS or JD preferred.
•10-15 years of successful experience in related field-demonstration of increasing responsibility-accomplishment in the responsibilities described above.
•Experience in the medical device industry preferred, relevant experience in the area of combination products(drug/devices) considered.
•Demonstrated excellent writing, editing skills in the preparation of technical documents
•Thorough knowledge of U.S. FDA regulatory laws and requirements. An understanding of regulatory laws in major international markets.
•High levels of professionalism, ethics and compliance.
•Strong written and oral communication skills
•Advanced degree may be substituted for experience, where applicable.
•20% of time may require domestic and/or international travel.
•German language ability a plus.

Forward current resumes directly to:
Alda Jorgenson
Recruiter
Heidelberg Engineering
ajorg@roadrunner.com
www.HeidelbergEngineering.com

Posted: April 17, 2009

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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@newportmedical.com
Salary: 

Job Description:

SUMMARY
The Regulatory Manager will be responsible for managing the regulatory submissions associated with new and revised designs.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties maybe assigned.

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.

Work with Japan affiliates on submissions in accordance with the Japan PAL.

Provide documentation in support of country specific product registrations as well as FDA registrations and listings.

Responsible for device tracking orders and post market requirements as required for product approvals.

An integral part of the design teams, assisting with development of project plans for new product introductions and modifications to existing devices.

Work with Marketing and Clinical Support on labeling and advertising development and approval.

Job Requirements:

EDUCATION and/or EXPERIENCE
Applicable Bachelor's degree or equivalent preferred (biological or engineering major)or comprehensive working knowledge and at least three (3) years of medical device experience with Class II or Class III devices and submissions. Must have successful track record with submissions written recently.

Must have an understanding of US Quality Systems Requirements for Medical Devices and CE marking requirements for EU. Understanding of Canadian, Australian and Japan Medical Device regulations desired.

Must be an 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.

Must have knowledge of Microsoft office, Visio and Project desired.

Posted: April 15, 2009

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Job Title: VP or Sr. Dir. QA/RA
Company Name: 
Location: South Orange County, CA
Job Type: Devices
Contact Name: Jeff Oros
Phone: 760-931-8987
Fax: 
Email: jeff@paragon-solutions.net
Salary: DOE

Job Description:

I am working with an exciting growth stage medical device company in the South Orange County area to bring on a VP or Sr. Director QA /RA professional and management team member.  We are looking for a professional with strong medical device experience, great leadership skills, and the ability to demonstrate a hands-on approach.  This role will weigh heavier on the Quality aspects within the company, but we need strong Regulatory capability as well.  In addition to leading the QA/RA department, we are looking for someone who can provide strategic leadership for the company as an executive team member.  If you are interested in learning more about this opportunity, please email a confidential copy of your CV to jeff{at}paragon-solutions.net.

Job Requirements:

Organizes and directs all regulatory and quality aspects in the development of mechanical components, equipment, and machinery of new products as well as novel medical devices in worldwide markets.
1.   Directs worldwide regulatory affairs and quality assurance activities for all current and future equipment, medical device and drug products.
2.   Manages the Quality Management System of the Company as its Quality Management Representative, in a rapidly growing manufacturing environment.
3.   Act as the liaison with external parties on matters relating to the Quality Management System.
4.   Directs all corporate QSR/ISO compliance activities and oversees all internal audits, complaint processing, and medical device reporting (e.g.  MDR, Vigilance and Mandatory reporting processes).
5.   Develops strategies and implements plans to obtain U.S. and foreign regulatory approvals.
6.   Defines and establishes policies and procedures according to regulatory requirements in cooperation with the appropriate Company senior managers.
7.    Assures inspections and audits conducted by State and Federal regulatory agencies, foreign governments and customers are managed professionally and effectively.
8.    Keeps abreast of new and emerging regulatory laws and regulations as they impacts the business and operations of the company.
9.    Direct design, development, coordination and continuous improvement to achieve quality goals.
10.    Accountable for submission of quality metrics.

Posted: April 15, 2009

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Job Title: Supervisor, US Product Safety & Compliance
Company Name: Abbott Medical Optics
Location: Santa Ana, CA
Job Type: Devices
Contact Name: Vickki Bueno
Phone: 
Fax: 
Email: 
WS: Apply on-line at www.amo-inc.com
Salary: 

Job Description:

Position supervises and coordinates activities of employees engaged in the Complaint Handling process. Supervisory duties include but are not limited to:
- entry of complaints
- review of complaints for regulatory reporting
- investigation of complaints
- closure of complaint files
- communication with complainants and regulatory agencies

May supervise both Non Exempt and Exempt associates including Healthcare Professionals.

The position is accountable for:
- timely and accurate product complaint entry, reporting, customer communication and complaint closure.
- optimizing complaint cycle time while maintaining compliance to all regulations.
- compliance with all FDA regulations governing complaints and MDRs.

In addition to supervising complaint handling, provide Quality Assurance leadership with product quality data, statistical analysis and complaint trending to drive product improvements and Corrective and Preventive Actions. In conjunction with Corporate QA, assists in field actions (including product recalls) as required. Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Lead or participate in various process improvement projects. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising and managing performance; addressing complaints and resolving problems.

Enhance and strengthen Product Safety's partnership with other key organizations within the company such as Technical Service and Clinical Support to improve the quality and capture rate of customer inputs regarding AMO products

Job Requirements:

Education / Field of Study:
BA/BS Chemistry, Engineering, Nursing, related Science or Microbiology or equivalent work experience

Experience:
- 6-8+ years in medical device and/or pharmaceutical industry in quality and compliance
- One to three years of supervisory experience
- Experience with complaint handling for serviceable medical equipment
- Strong people management skills
- Excellent verbal and written communication skills, excellent trainer of QS/complaint handling elements
-Past experience with Notified Bodies/FDA and ability to interact appropriately and authoritatively during the course of a facility level inspection
- Thorough knowledge of FDA/GMP/ISO requirements and regulations, with particular emphasis on complaint handling and adverse event reporting
- Ability to work well in a team environment.

Technical Skills:
Proficient computer skills, with good understanding of database management of complaint records plus Microsoft Word, Microsoft Excel

Posted: April 15, 2009

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Job Title: Regulatory Affairs Project Manager
Company Name: Microvention, Inc.
Location: Aliso Viejo/Tustin, CA
Job Type: Devices
Contact Name: Juli Evans
Phone: 949-461-3314
Fax: 
Email: hr@microvention.com
Salary: DOE

Job Description:

Scope:  Assists the Director, RA with management of regulatory submissions and compliance programs for new products on a world-wide basis.

Responsibilities:  This individual plays a key role in the preparation of regulatory submissions (510(k)s, Design Dossiers, PMAs) for intravascular, catheter-based products.

-Represents Regulatory Department on new product development teams, interacts with R&D, QA and other disciplines, and supports submissions to regulatory bodies in the US, EU, and other jurisdictions
-Develops global regulatory strategies for new products and process changes
-Prepares submissions and coordinate review by government agencies.
-Reviews labeling and product documentation for new products and process changes
-Manages the timing of assignments and submissions and prepare status report

Job Requirements:

Requisite Experience:
1.Participates in hosting outside regulatory bodies during plant inspections
2.Concentrated knowledge of U.S. & EC regulatory submission requirements  (510(k)s, Design Dossiers)
3.Strong knowledge of FDA QSR and ISO 13485:2003
4.Excellent writing skills are required and strong interpersonal skills, problem solving, and team-building skills are essential
5.Works independently under very general direction
6.A Bachelor Degree in Science, Engineering, or Medical Technology or related fields
6.Five to seven years experience in Regulatory Affairs
7.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 hr@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: April 14, 2009

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Job Title: Manager, Quality Engineering
Company Name: Microvention, Inc.
Location: Tustin, CA
Job Type: Devices
Contact Name: J Evans
Phone: 949-461-3314
Fax: 949-362-0968
Email: hr@microvention.com
Salary: DOE

Job Description:

Scope:
Ensures reliability of all MicroVention products by resolving quality issues in support of product development teams and manufacturing engineering.  Ensures regulatory compliance to applicable FDA and ISO requirements.  Ensures product quality through the management Quality Engineers.

Responsibilities:
1.Lead QA engineers that ensure regulatory compliance to applicable FDA and ISO requirements
2.Lead QA engineers that provide Quality Assurance review for new product development teams
3.Lead QA engineers that provide Quality Assurance review to Manufacturing Engineering
4.Lead QA engineers that maintain adherence to Quality System requirements
5.Provide direct Quality Engineering support to Manufacturing and R&D teams
6.Responsible for personnel resource prioritization and allocation

Skills:
1.Knowledge of medical product manufacturing
2.Ability to understand the technology related to MicroVention’s products
3.Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques)
4.Computer skills including MS Word & Excel

Job Requirements:

Requisite Experience:
1.Degree in related field
2.A minimum of seven years of related medical device experience
3.A minimum three years management experience
4.Good communication skills

Please email resume in MS Word format to hr@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: April 9, 2009

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Job Title: Senior Quality Engineer
Company Name: (not provided)
Location: San Diego, CA
Job Type: Devices
Contact Name: 
Phone: 858-550-9999 x5630
Fax: 
Email: mj2coleman@msn.com
Salary: Commensurate with experience

Job Description:

Assures product quality requirements are in compliance with FDA, ISO,and other national and international standards, as applicable. Provide Q.A. technical support to operational areas (i.e. Manufacturing and Product Development) in order to ensure product quality and safety. Manage and direct Calibration System.   Support/Coordinate the Corrective Action (CAPA) program, as required.  Support the product complaint investigations.  Interface with other department to assure quality requirement are met during product development.

Job Requirements:

Manage QC Inspection Department in performance of component, material and product inspections.
Implements changes to products and manufacturing to improve quality and reliability and to address improvement of process, design, or materials.
Performs equipment, product, and process qualifications/validations. This includes writing the protocol, execution of the validation, write the final report and update applicable procedures and documentation accordingly.
Acts as the Quality Assurance representative to design controls teams.
Provides QA investigational support for product NCRs, CAPAs and Product Complaint Reports.

Posted: April 9, 2009

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Job Title: Business Development Representative
Company Name: Terrosa Technologies, Inc.
Location: Thousand Oaks, CA
Job Type: Biologics/Biotechnology
Contact Name: Kim Terry
Phone: 805-277-1922
Fax: 866-224-4102
Email:  Careers@Terrosatech.com
Salary: Commission Sales

Job Description:

Terrosa Technologies is seeking a clinical trials specialist to market and sell a new Clinical Trials Management System (CTMS). This breakthrough product is delivered as a subscription service over the Internet, lowering the acquisition and operational costs for our customers.

Job Requirements:

The person(s) we seek will have a sales history and contacts in the area of Clinical Trials, with a working knowledge of the Clinical Trials process. We are also open to working with persons or entities that are interested in representing our product as part of a larger product line offering.

Posted: April 4, 2009

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Job Title: Clinical Project Manager
Company Name: Promedica International
Location: Costa Mesa, CA
Job Type:  Devices, Drugs, IVD, Biologics/Biotechnology
Contact Name: Shannon Sotddard
Phone: 714-460-7363
Fax: 714-460-7364
Email:  stoddard.s@promedica-intl.com
Salary: 

Job Description:

The Clinical Services Project Manager guides and directs team performance of all contracted activities for assigned projects, and serves as the company’s primary interface with the associated clients. Responsibilities include project team staffing, adherence to established budget and timelines, quality of Promedica’s work products generated throughout the project, and regular status reports for our clients.  The position reports to the Executive Vice President of the division.

Job Requirements:

Qualified candidates must have a Bachelor’s degree, a minimum of 4 years’ clinical trial monitoring, and at least 1 year project management experience.  To facilitate understanding of our clients’ work environment, candidates must have been employed a minimum of 2 years within the medical product manufacturing industry.  Other experience in the development, analysis, and implementation of scientifically valid human clinical research in compliance with state and federal regulations and corporate policies is a plus.

Posted: March 31, 2009

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Job Title: Director, Regulatory Compliance
Company Name: Intuitive Surgical
Location: Sunnyvale, CA
Job Type:  Devices
Contact Name: Keri Christman
Phone: 408-523-6935
Fax: 408-523-1390
Email:  keri.christman@intusurg.com
Salary: 

Job Description:

Intuitive Surgical is hiring for an experienced Director of Regulatory Affairs for their headquarters in Sunnyvale, CA. For more information and to apply, please visit: http://www.intuitivesurgical.jobs

Job Requirements:

Competency Requirements: (Competency is based on: education, training, skills and experience.)
In order to adequately perform the responsibilities of this position the individual must:

Minimum 8 years relevant regulatory compliance experience with 5+years of experience in complaint reporting, CAPA, internal audits and field actions, document control, for a medical device company

Bachelors degree or higher, degree in sciences or engineering a plus

Minimum of 8 years experience leading teams with a solid track record in hiring and developing team members

Strong verbal and written communication skills, proven ability to translate technical documentation into effective compliance documents

Exceptional interpersonal skills and excellent ability to work well with cross-functional teams

Excellent project management skills

Experience working directly with the FDA, Notified Bodies and other governmental agencies on Regulatory Compliance matters on a global basis

Posted: March 27, 2009

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Job Title: Senior Quality Engineer
Company Name: Confidential Search
Location: South Orange County
Job Type: Devices
Contact Name: Kathryn Henslee
Phone: 
Fax: 
Email:  Kathrynhenslee@aol.com
Salary: Competitive with equity

Job Description:

This is a prime opportunity for you to join an Emerging Medical Device company in which the products are on the market and rapidly taking over. These products have even been featured on several TV programs! In addition, new product extensions are making their way from R&D into Manufacturing. The Senior QE will be responsible to ensure compliance with product specifications and quality system requirements. Support the implementation of QSR, ISO13485, MDD and CMDR-compliant quality systems. Formulate inspection instructions and determine equipment, gage requirements and sampling plans for receiving, in-process and final inspection. Provide hands-on QE support to Manufacturing floor, as required. Provide technical and Quality 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 validation reports. Use statistical tools to analyze data, make acceptance decisions and improve process capability (Six Sigma, SPC, DOE). The Supervision of QC inspectors or other Quality personnel, as required. Other duties may be assigned.

Job Requirements:

BS degree in mechanical engineering or related discipline; CQE preferred.  Minimum three years experience as a Quality Engineer in the medical device industry. Thorough knowledge of Quality systems and processes including GMP, QSR, and ISO requirements. Familiarity with product development life cycle, manufacturing processes and equipment, test methods, inspection techniques and product/process validation. Able 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. Previous experience working within a small, fast paced environment.

Posted: March 19, 2009

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Job Title: Quality Assurance Manager
Company Name: The Byran Company, Inc.
Location: Huntington Beach, CA
Job Type: Devices
Contact Name: Sean Okutsu
Phone: 714-841-9808
Fax: 714-841-9637
Email:  sokutsu@byranco.com
Salary: Open - DOE

Job Description:

The Quality Assurance Manager is the management representative and head of the company's quality organization. Responsible for overseeing both the quality system and compliance by all departments and personnel with the requirements of the quality system. The QA Manager is responsible for establishing, implementing and maintaining the quality system regulation (QSR) for medical devices as well as ISO standards and internal standards throughout the company.

Job Requirements:

Quality Assurance Manager must have a minimum of 10 years quality system management experience, preferable in the medical device industry with experience in managing quality assurance departments. In-depth knowledge and understanding of the Code of Federal Regulations Part 21 subsection 820, for the medical device industry, with experience negotiating with the US FDA on compliance and regulatory issues.

Posted: March 17, 2009

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Job Title: Clinical Research Associate II
Company Name: Edwards Lifesciences
Location: Irvine, CA
Job Type:  Devices
Contact Name:  Patty Vasquez
Phone: 
Fax: 
Email:  Patty_Vasquez@Edwards.com
Salary: 

Job Description:

For onsite technical support, candidate will provide case support as necessary, attend first implants of new products and collect customers input on device/procedure performance' lesson learned, and educate and train physicians, hospital personnel and hospital staff on technical matters relating to our products - enabling them to conduct training for their personnel (train the trainer).
For in-house support, candidate will provide feedback from first clinical cases to R&D engineers & the marketing and serve as a liaison between R&D, and Marketing and the implanting physicians. The selected candidate will also serve as clinical engineering resource for new product development teams, interfacing with R&D and Marketing; attend animal labs and feasibility phases for new products; and train the clinical team on new devices.
For clinical trail support, the candidate will ensure that all research related activities are compliant to regulatory and company guidelines; monitor inventory levels, initiate shipments and movements of investigational products according to regulatory and company guidelines.
Candidate will be the primary clinical contact for site management during clinical trials; work with assigned sites/investigators ensuring and documenting clinical site and investigator readiness for participation in aninvestigation; and create, compile and verify required regulatory, legal, and financial documentation in order to ensure successful study start-up (e.g., site initiation visits, product shipment, start of pt enrollment

Job Requirements:

Minimum of three years experience in interventional cardiology or cardiothoracic surgery is preferred.

A Bachelor's degree in a biological, scientific, or clinical is required. A bachelor's degree is required; an advanced degree is a plus. Registered Nursing Degree (RN), Certified Radiology Technician (CRT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) preferred.

·          Must possess effective communication skills (written and verbal) with technical, non-technical and clinical personnel as well as internal and external customers

·          Candidate must have the ability to manage several parallel tasks at once

·         Must demonstrate a high degree of creativity, foresight, and sound judgment in planning, organizing, and guiding programs and activities

·          Ability to work positively through confrontation and/or conflicting ideas

·          Good presentation skills with the ability to present material comfortably

·          Strong time and territory management skills

·          Must be proficient with Microsoft office suite

·          Must be able to travel 50-75%

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=3347

Posted: March 6, 2009

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Orange County Regulatory Affairs Discussion Group
Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Email: ksyre@cox.net