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Senior Regulatory Affairs Specialist

Company Name: Caldera Medical
Location: Aguora Hills, CA
Job Type: Full Time
Contact Name: Angela Attardo
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Message from the Hiring Manager: 
Please visit our Careers page and apply directly:

Job Description

Duties and Responsibilities:

  • Plan, prepare, coordinate, track, follow-up, provide guidance, manage and obtain clearances, registrations and submissions for medical device submissions in US and OUS.
  • Work with project teams through all phases of product development and provide Regulatory Strategy.
  • Work with project teams and responsible leaders to provide compliance/requirements for products, processes and procedures.
  • Represent Regulatory in Quality Management System implementation and updates.
  • Participate in the planning, conduct, and reporting for external audits as requested.
  • Remain current on developments in field(s) of expertise, regulatory requirements and industry trends.  Monitor impact of changing regulations on submission strategies and provide interpretation and strategy on compliance.

Objectives and Measurable Performance Accountabilities: 

  • Authoring PMA annual report, supplements, amendments
  • Authoring/Supporting 510(k) submission, responses, memos to file
  • Researching applicable standards and applications to product, processes, etc.
  • Supporting international product registrations, i.e. CE or CMDCAS

Job Requirements

Required Knowledge, Skills and Abilities:

  • S. degree in a biomedical, biotechnology, regulatory sciences, engineering.
  • 3 years’ experience in US Regulatory Affairs in the Medical Device industry.
  • 2 years’ experience working for a company with less than $50 million in revenue
  • Experience with Class II (and above) medical devices

Desired Knowledge, Skills and Abilities:

  • Certifications with RAPS, ASQ, CQE preferred
  • International regulatory affairs experience
  • Excellent interpersonal and communication skills
  • Strong project planning and organizational skills
  • Ability to prioritize effectively, ability to ensure all projects are completed in an effective and timely manner
  • Possess strong work ethic; think independently, and problem solve,
  • Self motivated with a desire to take initiative and look for ways to improve processes and create efficiencies;
  • Exceptional follow-through and attention to detail
  • Extremely flexible, highly organized and able to shift priorities
  • Proficient in MS Office

Again, Please visit our Careers page and apply directly: