Regulatory Affairs Specialist - Medical Devices; FDA/ISO
Listed on 2026-10-09
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Healthcare
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Quality Assurance - QA/QC
FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to support compliance with US FDA medical device regulations and ISO 13485 standards. The role covers pre-market submissions (510(k)/PMA), EU documentation, and cross‑functional collaboration across R&D, Quality, and Regulatory teams.
The candidate will coordinate registration activities, maintain records for adverse events, and participate in internal audits and remediation efforts to ensure ongoing regulatory
Step into the Regulatory Affairs Specialist
- Medical Devices (FDA/ISO) role at Fujifilm in Tallahassee, FL, United States and grow with us.
The advertised compensation is 74.000 - 91.000.
We aim to respond to suitable candidates as soon as possible.
Full responsibilities and requirements are described in the listing above.
Learn more about the Regulatory Affairs Specialist
- Medical Devices (FDA/ISO) role in the description above.
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