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Regulatory Affairs Manager

  • Type Permanent
  • Salary US$120000 - US$150000 per annum + competitive
  • Location San Francisco, California
  • Sectors Regulatory Affairs (RA)

A world renowned Class III Medical Device company is looking for a qualified Regulatory Affairs professional to join their Bay Area site as an Regulatory Affairs Manager.

Responsibilities:

~Manage regulatory team consisting of direct reports

~Lead all new product submissions (IDEs, 510(k)s, PMAs, etc.)

~Develop, plan and execute regulatory strategy to ensure approval/clearance in a timely manner

~Support cross-functional teams as needed

Qualifications:

~Bachelor's Degree in a Life Science (MS/MBA/PhD preferential)

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

~Managerial experience

~Class III Device experience and PMA submission experience

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