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Senior Regulatory Affairs Specialist

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.

Responsibilities:

~ 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

Qualifications:

~ 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.