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Regulatory Affairs Specialist – Medical Devices; Remote

Remote / Online - Candidates ideally in
Bangor, Penobscot County, Maine, 04401, USA
Listing for: Fujifilm
Remote/Work from Home position
Listed on 2026-09-01
Job specializations:
  • Healthcare
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 74000 - 91000 USD Yearly USD 74000.00 91000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Affairs Specialist – Medical Devices (Remote)

FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to support U.S. FDA regulatory requirements and ISO 13485.

The role includes 510(k)/PMA submissions, EU submissions, and cross-functional collaboration with Engineering, Quality, and Service teams. Responsibilities include registrations, post-market activities, and regulatory communications with occasional travel up to 25%.

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