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Global Regulatory Affairs Specialist - Medical Devices
Job in
Santa Ana, Orange County, California, 92725, USA
Listed on 2026-08-26
Listing for:
Nihon Kohden Orange Med
Full Time
position Listed on 2026-08-26
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate global product registrations and regulatory submissions across markets. The role ensures timely documentation, maintains records, and collaborates with cross‑functional teams to meet regulatory requirements.
The successful candidate will manage FDA 510(k) submissions, monitor regulatory changes, and provide support for post‑market activities, labeling, and compliance throughout the product lifecycle.
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