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Remote Medical Device Regulatory Affairs Specialist
Remote / Online - Candidates ideally in
Montgomery, Montgomery County, Alabama, 36136, USA
Listed on 2026-07-20
Montgomery, Montgomery County, Alabama, 36136, USA
Listing for:
Fujifilm
Remote/Work from Home
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to support ongoing compliance with U.S. FDA requirements, ISO 13485, and related standards.
The role encompasses submissions (510(k), PMA), EU documentation, and cross‑functional coordination to maintain regulatory readiness across US operations. The ideal candidate will bring 2+ years of FDA-regulated experience or RAC with 4+ years, strong communication skills, and the ability to manage multiple regulatory
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