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Senior Regulatory Affairs Analyst/Manager

Our client, a medical device company is looking for an experienced Senior Regulatory Affairs Analyst/Manager to join their molecular diagnostic team based in the Bay Area. Reporting directly into the Director of Regulatory Affairs, this is a rare opportunity to work with a renowned company working on next generation devices.

Responsibilities:

  • Develop and implement regulatory strategies for products; including RA support to company project teams and external entities
  • Determine and assure product submission requirements are executed and timely
  • Facilitate regulatory analysis of pre- and post- market products; including review/approval of design files and technical files
  • Develop and foster positive relations with all applicable regulatory authorities

Skills:

  • B.S. in related science
  • 4+ years experience in Regulatory Affairs
  • Hands-on experience with either PMA or 510(k) submissions
  • Direct experience with FDA and international regulatory authorities

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