Remote Regulatory Affairs Specialist | FDA/ISO

FUJIFILM Healthcare Americas Corporation is seeking Regulatory Affairs support to maintain full compliance with U.S. FDA medical device regulations, ISO 13485, and applicable laws.

In this role you will manage device marketing authorization, 510(k) and PMA submissions, EU MDR responsibilities, QMS data, and cross‑functional collaboration with Customer Service, Quality, and R&D. Travel up to 25% may be required.