Remote Regulatory Affairs Specialist; FDA/ISO
Remote / Online - Candidates ideally in
Honolulu, Honolulu County, Hawaii, 96813, USA
Listed on 2026-09-01
Honolulu, Honolulu County, Hawaii, 96813, USA
Listing for:
Fujifilm
Remote/Work from Home
position Listed on 2026-09-01
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to support ongoing U.S. FDA medical device regulatory compliance, ISO 13485, and related global standards.
This role involves directing responsible personnel, handling submissions (510(k), PMA), EU MDR responsibilities, and collaboration across Regulatory Affairs, Quality, and Operations. You will prepare technical documentation, assess information for safety signals, manage field actions, and support
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