More jobs:
Regulatory Affairs Specialist; IVD Innovation
Job in
Dallas, Dallas County, Texas, 75215, USA
Listed on 2026-09-01
Listing for:
Remote Jobs
Full Time
position Listed on 2026-09-01
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
Waters Corporation seeks a Regulatory Affairs Specialist (Innovation) to guide regulatory strategy for new product development in vitro diagnostic devices and related software. You will prepare FDA submissions (IDE, PMA, 510(k)), De Novo, and EU IVDR dossiers, coordinating with cross-functional teams across R&D, Quality, and Marketing.
You thrive in regulated healthcare environments, enjoy solving complex regulatory challenges, and drive products from development to approval while maintaining
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