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Remote Regulatory Affairs Specialist: FDA & ISO
Remote / Online - Candidates ideally in
Lincoln, Lancaster County, Nebraska, 68511, USA
Listed on 2026-07-20
Lincoln, Lancaster County, Nebraska, 68511, 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 ensure ongoing compliance with U.S. FDA medical device requirements, ISO 13485, and other international standards.
This remote US role supports submissions (510(k), PMA) and global regulatory documentation in collaboration with cross‑functional teams. You will coordinate regulatory activities, manage registrations, and drive filings while interacting with Service, R&D, Marketing, and Quality Assurance to
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