Regulatory Affairs Lead — FDA & EU MDR (Medical Devices)

FUJIFILM Healthcare Americas Corporation is seeking a Regulatory Affairs professional to support compliant regulatory activities for U.S. FDA medical device requirements, ISO 13485, and international standards.

You will manage submissions, documentation, and cross-functional collaboration across R&D, Quality, Service, and Regulatory teams. The role includes oversight of 510(k)/PMA submissions, EU MDR alignment, and post-market activities, with a strong emphasis on documentation, risk assessment,