Senior Specialist, Quality & Regulatory Affairs
Beckman Coulter Diagnostics
Senior Specialist, Quality & Regulatory Affairs
Danaher is seeking a Senior Specialist, Quality & Regulatory Affairs to support Quality and Regulatory compliance activities for the Netherlands and broader European operations, with a focus on Economic Operator responsibilities under EU legislation. The role is primarily on-site in Woerden, Netherlands, and 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
Danaher is seeking a Senior Specialist, Quality & Regulatory Affairs to support Quality and Regulatory compliance activities for the Netherlands and broader European operations, with a focus on Economic Operator responsibilities under EU legislation. The role is primarily on-site in Woerden, Netherlands, and 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, with initial emphasis on supporting compliance with Importer and Distributor obligations (e.g., Articles 13 and 14 IVDR/MDR).
- Support the development, implementation, and maintenance of sustainable EO compliance processes across the region.