Senior Regulatory Affairs Specialist

  • Type Permanent
  • Salary US$100000 - US$150000 per annum + competitive
  • Location San Francisco, California
  • Sectors Regulatory Affairs (RA)

A growing biotechnology company is looking for a Senior Regulatory Affairs Specialist to join their growing team. The role will focus on regulatory strategy and new product submissions for Class II SaMD devices, with a portfolio of new products in the pipeline.


~ Contribute to company's overall regulatory strategy; aid in introduction of new products to all cross-functional teams (i.e. design change impacts)

~ Provide internal awareness and knowledge of regulatory standards and changes both domestically and internationally

~ Support new product submissions to obtain timely clearance; 510(k)/De Novo/CE Mark

~ Work directly with FDA and international regulatory bodies


~ Bachelor's degree in a Scientific field

~ 5+ years experience in Regulatory Affairs within the Medical Device industry

~ Submission experience (510(k), PMA, CE Mark, etc.)

~ SaMD experience a plus

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