Senior Regulatory Affairs Specialist

ReShape Lifesciences has a fantastic opportunity for Senior Regulatory Affairs Specialist to join our growing team. This role is responsible for providing support to achieve product clearance and/ or approval in the U.S. and the rest of the world.

We are located in San Clemente, CA and offer a hybrid work environment.

ESSENTIAL JOB FUNCTIONS (including but not limited to):

  1. Prepare and submit regulatory files and regulatory reports as needed, including annual PMA reports, PMA submissions, 510(k), Pre-submissions, technical files, change notification and international license renewals.
  2. Take a lead role in drafting U.S. and O.U.S. submissions.
  3. Assess product changes and possible regulatory impact and serve as external standards and compliance expert.
  4. Support communication to FDA and international regulatory agencies, including but not limited to formal submissions, e-mails and telephone calls with reviewers.
  5. Support activities associated with maintaining and revising, as necessary, Regulatory Standard Operating Procedures.
  6. Provide regulatory guidance and evaluation of promotional activities associated with the Company’s products worldwide.
  7. Support internal and external audits (e.g. FDA).

EDUCATION/EXPERIENCE

Bachelor’s Degree Required

3+ year Regulatory experience

Understanding of U.S. and international regulatory requirements associated with regulatory submissions.

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