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Remote Regulatory Affairs Specialist - Medical Devices

Remote / Online - Candidates ideally in
Lexington, Middlesex County, Massachusetts, 02173, USA
Listing for: FUJIFILM Holdings America Corporation
Remote/Work from Home position
Listed on 2026-08-22
Job specializations:
  • Healthcare
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below

FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to ensure full compliance with U.S. FDA medical device regulations, ISO 13485 standards, and related laws.

You will oversee marketing authorizations, registrations, and technical documentation, while collaborating with design, QA, and service teams. Ideal candidates have a Bachelor’s in a related field with RA experience in FDA-regulated environments and RA certification.

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