Senior Specialist, Quality & Regulatory Affairs
Beckman Coulter Diagnostics
Senior Specialist, Quality & Regulatory Affairs
Senior Specialist, Quality & Regulatory Affairs needed for Danaher Diagnostics in Woerden, Netherlands. The role supports Quality and Regulatory compliance for the Netherlands and broader European operations, focusing on Economic Operator responsibilities under EU legislation. Requires a Bachelor's degree in Life Sciences or related field, experience in Quality/Regulatory Affairs in the Medical Device/IVD industry, and fluency in English and Dutch.
Senior Specialist, Quality & Regulatory Affairs
Senior Specialist, Quality & Regulatory Affairs needed for Danaher Diagnostics in Woerden, Netherlands. The role supports Quality and Regulatory compliance for the Netherlands and broader European operations, focusing on Economic Operator responsibilities under EU legislation. Requires a Bachelor's degree in Life Sciences or related field, experience in Quality/Regulatory Affairs in the Medical Device/IVD industry, and fluency in English and Dutch.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Perform general Q&RA activities in support of the Netherlands site, aligned with Commercial Q&RA Centre of Excellence and regional priorities.
- Maintain, implement, and continuously improve QMS processes and infrastructure to ensure best-in-class compliance and strong business support for the Commercial organization.
- Act as a Q&RA subject matter expert (SME) for Economic Operator obligations across European regulations.
- Support compliance with Importer and Distributor obligations (e.g., Articles 13 and 14 IVDR/MDR), in collaboration with Country Regulatory Affairs and other COE functions.
- Support the development, implementation, and maintenance of sustainable EO compliance processes across the region.