EU Quality & Regulatory Specialist – IVDR/MDR & EO

Danaher Corporation; Woerden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Danaher Diagnostics in Woerden, Netherlands, seeks a Specialist, Quality & Regulatory Affairs to support Q&RA activities for the Netherlands and broader European operations, with emphasis on Economic Operator obligations.

The role reports to the Quality and Regulatory Affairs Manager (UK & CH) and is primarily on-site in Woerden. Requires a Life Sciences degree and fluency in English and Dutch.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, or related discipline.
• Experience in Quality and/or Regulatory Affairs within the Medical Device and/or IVD industry.
• Lead auditor certification (ISO 9001).
• Working knowledge of EU regulatory frameworks, including IVDR and/or MDR.
• Fluent in English and Dutch (written and verbal).

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 IVDR and MDR.
• 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.

Skills

Quality management

Regulatory affairs

Lead auditor

EU regulatory knowledge

Education

Bachelor's degree in Life Sciences

Job description

Danaher Diagnostics in Woerden, Netherlands, seeks a Specialist, Quality & Regulatory Affairs to support Q&RA activities for the Netherlands and broader European operations, with emphasis on Economic Operator obligations.

The role reports to the Quality and Regulatory Affairs Manager (UK & CH) and is primarily on-site in Woerden. Requires a Life Sciences degree and fluency in English and Dutch.