Waters Salamanca is seeking a Regulatory Affairs Specialist to drive regulatory strategies for in vitro diagnostic devices across the product lifecycle.
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You will prepare submissions, maintain technical documentation, and support integral market access.
Collaborating with R&D;, QA, Manufacturing, Clinical Affairs, Medical Affairs and Marketing, you will ensure compliance with FDA, xghoner EU IVDR 2017/746, UK regulations and Health Canada, translating regulatory requirements into actionable plans.