Global Ivd Regulatory Affairs Strategist
Hace 1 semana
Madrid, España
Becton Dickinson
Jornada completa
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Waters Salamanca is seeking a Regulatory Affairs Specialist to drive regulatory strategies for in vitro diagnostic devices across the product lifecycle. You will prepare submissions, maintain technical documentation, and support global market access.
Collaborating with R&D, QA, Manufacturing, Clinical Affairs, Medical Affairs and Marketing, you will ensure compliance with FDA, EU IVDR 2017/746, UK regulations and Health Canada, translating regulatory requirements into actionable plans.
Collaborating with R&D, QA, Manufacturing, Clinical Affairs, Medical Affairs and Marketing, you will ensure compliance with FDA, EU IVDR 2017/746, UK regulations and Health Canada, translating regulatory requirements into actionable plans.