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Senior Regulatory Affairs Specialist - SaMD & FDA ; k

Job in Macon, Bibb County, Georgia, 31297, USA
Listing for: BioTalent Ltd
Full Time position
Listed on 2026-02-12
Job specializations:
  • Healthcare
    Medical Science Liaison, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Specialist - SaMD & FDA 510(k)
A growing medical device company is seeking a Senior Regulatory Affairs Specialist to support FDA 510(k) submissions for software-driven medical devices. The ideal candidate has over 5 years of experience in Medical Device Regulatory Affairs and a background with digital health technologies. This hands-on role offers high visibility within a lean team and competitive compensation. The position is hybrid, requiring 1-2 days onsite in Southern California.
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Position Requirements
10+ Years work experience
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