Regulatory Affairs Specialist
Danaher · Irvine
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- Company
- Danaher
- Location
- Irvine
- Employment type
- Full-time
- Salary
- $80,000 - $100,000
- Posted
- October 2, 2026
About this job
The Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances. This position reports to the Director, Regulatory Affairs and is part of the Regulatory Affairs team located in Irvine, CA and will be an on-site role. In this role, you will have the opportunity to: Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents…
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