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Regulatory Affairs Specialist - Medical Devices; Remote

Remote / Online - Candidates ideally in
Columbus, Franklin County, Ohio, 43224, USA
Listing for: Fujifilm
Remote/Work from Home position
Listed on 2026-07-20
Job specializations:
  • Science
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 90000 - 130000 USD Yearly USD 90000.00 130000.00 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 ongoing compliance with FDA medical device regulations, ISO 13485, and related standards. This remote US role partners with cross‑functional teams to prepare submissions (510(k), PMA), maintain registrations, and oversee regulatory documentation for current and new products.

You will analyze incoming data, manage adverse events, support field actions, and coordinate with global teams to ensure timely

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