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Senior Regulatory Affairs Specialist

  • Job type Permanent
  • Salary competitive
  • Location Santa Clarita, California
  • Sector Regulatory Affairs

My Class II/III medical device client in Santa Clarita is searching for a Sr. Regulatory Affairs Specialist to lead the domestic submissions for their ground breaking sub-dermal stimulator product onto the market. The Senior Specialist will be leading the team for international and domestic 510(k) submissions. This is a full time direct-hire opportunity with full benefits.

Applicants must have:

510(k) authorship

EU regulatory background (CE mark and technical files)

Adaptable thinking in the regulatory space

This positions offers the following:

A base salary ranging up to 110k with a 10% quarterly bonus dependent on skill level

The ability to drive the 510k submission process to push life changing devices onto the market

If this sounds like an opportunity you are interested in, or know of someone who might be, please reply to this position as I will be contacting the best candidates for a qualification call as they would ideally like to have the position filled by mid-June.

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