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Remote Regulatory Affairs Specialist FDA/ISO Expert
Remote / Online - Candidates ideally in
Badger, Fairbanks North Star Borough, Alaska, USA
Listed on 2026-09-01
Badger, Fairbanks North Star Borough, Alaska, USA
Listing for:
Fujifilm
Remote/Work from Home
position Listed on 2026-09-01
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
FUJIFILM Healthcare Americas Corporation seeks a Regulatory Affairs professional to support compliance with U.S. FDA medical device requirements, ISO 13485, and related regulations across product lines.
This role ensures ongoing regulatory readiness and alignment with global standards. Key duties include designated responsibilities for device marketing authorization and facility registrations (MDSAP), Pre-Market submissions (510(k), PMA), EU MDR, technical documentation, complaint trend
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