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Regulatory Affairs Manager

Company Name: ReShape Lifesciences
Location: San Clemente, CA
Job Type: Full Time
Contact Name: Brandi Drew 
Phone:
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Based on Experience

Job Description 

  1. Represent Regulatory Affairs in project meetings to assess product changes and possible regulatory impact.
  2. Maintain up-to-date knowledge on domestic and international regulatory requirements, regualations, standards, and guidances and ensure effective communication to the projext teams and management.
  3. Supports communication to FDA and International Regulatory Agencies.
  4. Manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis.
  5. Manage the preparation and maintenance of regulatory submissions including but not limited to: PMA Supplements, PMA Annual Reports and Post Approval Study Reports, Design Dossiers and Technical Files.
  6. Manage customer complaints and corresponding medical device reporting (MDR) and vigilance reporting processes.
  7. Support CAPA, NCMR and Complaint investigations as needed.
  8. Take a lead role in maintaining and revising, as necessary, Regulatory Standard Operating Procedures
  9. Review and approve Change Orders, test protocols and reports, risk management documets, labeling and promotional material.
  10. Develop and maintain association with outside organizations and institutions pertinent to the interests and needs of the department and the Company.
  11. All other duties and tasks as required and requested by Director of RA/QA or their designee.

 
Job Requirements 

Education:                       Bachelor’s degree engineering, science, business or related field 

Experience:                     Five years plus in regulatory affairs
                                        Ten years experience within the medical device industry
                                        Proven experience in taking a lead role in drafting PMA submissions
                                        Successful record of reviewing product modifications for regulatory impact
                                        Demonstrated background of understanding and applying knowledge of basic
                            regulatory requirements for new products and promotional materials