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.