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Senior Regulatory Affairs Lead – FDA Strategy k Expert

Job in Sarasota, Sarasota County, Florida, 34243, USA
Listing for: Novanta
Full Time position
Listed on 2025-12-01
Job specializations:
  • Healthcare
    Healthcare Management
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Lead – FDA Strategy & 510(k) Expert
A leading healthcare technology company in Sarasota is looking for a Senior Regulatory Affairs Specialist to lead FDA submission activities. This role requires expertise in regulatory strategy and compliance, including preparing 510(k) applications, and acting as a liaison with regulatory authorities. Ideal candidates have over 5 years of experience and a Bachelor's degree, along with advanced training in regulatory affairs for medical devices.

We offer an empowering workplace culture and opportunities for growth.
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Position Requirements
10+ Years work experience
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