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Regulatory Affairs Lead — FDA & EU MDR (Medical Devices
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-08-15
Listing for:
FUJIFILM Holdings America Corporation
Full Time
position Listed on 2026-08-15
Job specializations:
-
Healthcare
Healthcare Compliance, Healthcare Management
Job Description & How to Apply Below
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,
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