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Remote FDA Regulatory Affairs Specialist – IVD

Remote / Online - Candidates ideally in
Norman, Cleveland County, Oklahoma, 73019, USA
Listing for: IMMY
Remote/Work from Home position
Listed on 2026-08-28
Job specializations:
  • Healthcare
    Healthcare Compliance, Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 70000 - 110000 USD Yearly USD 70000.00 110000.00 YEAR
Job Description & How to Apply Below

IMMY is seeking a Regulatory Affairs Specialist – FDA to lead US regulatory submissions for in vitro diagnostic products and secure required FDA clearances, registrations, listings, and licenses to keep products on the U.S. market.

The role emphasizes thorough documentation, cross-functional collaboration, and compliance with FDA and ISO 13485 standards. The ideal candidate has a bachelor’s degree in a related field with 2+ years in a US FDA-regulated environment, strong technical writing, and

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