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Regulatory Affairs Specialist

  • Job type Permanent
  • Salary Up to US$100000 per annum + competitive
  • Location San Francisco, California
  • Sector Regulatory Affairs

A growing Class II & Class III Medical Device company is looking for a Regulatory Affairs Specialist to join their team. The role will report directly into the Director of Regulatory Affairs and be based out of the Bay Area. Offering flexible work hours and WFH days this is a rare opportunity to rapidly advance your regulatory career with a tight knit team.

Responsibilities:

  • Plan, coordinate, prepare all domestic and international regulatory submissions
  • Ensure all existing approvals and regulatory documents are maintained
  • Provide regulatory input to cross-functional departments
  • Support development of regulatory strategy for new and/or modified product(s)
  • Review all tests that directly support regulatory submissions

Qualifications:

Essential -

  • Bachelor's Degree in a Life Science or Engineering
  • 3+ years of experience in Regulatory Affairs within the Medical Device, Diagnostic or Bio-Tech industry
  • Class II and/or Class III device experience
  • FDA submissions, Technical File/Design Dossier, and regulatory registration experience

Preferred -

  • Advanced degree (Masters/PhD) in a Scientific field
  • SaMD experience
  • IDE, PMA submissions

Sthree US is acting as an Employment Agency in relation to this vacancy.