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Regulatory Affairs Specialist (Senior)

My Client, a medical device company whose mission is to improve the lives of patients with cancer is searching for an experienced Regulatory Affairs professional to join their regulatory team based out of their Bay Area site.

Responsibilities:

  • Participate in the development and execution of the company's regulatory strategy
  • Support all regulatory documentation and submissions (New Products); focused on US, EU, and Canada
  • Work cross-functional and provide regulatory expertise to all relevant departments
  • Cultivate and foster meetings/relationships with FDA and additional regulatory bodies

Qualifications:

  • Bachelor's Degree in a Life Science
  • 5+ years of Regulatory Affairs experience within the Medical Device industry
  • Experience working with the FDA and international regulatory bodies
  • Successful submission experience (510k, Technical Files)

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