EU Quality & Regulatory Specialist — IVDR/MDR & EO

Danaher Corporation; Zwolle; On-site; EUR 60,000 - 90,000; Full time

Job summary

Danaher Corporation is seeking a Specialist, Quality & Regulatory Affairs to support Quality and Regulatory compliance for the Netherlands and broader European operations, with emphasis on Economic Operator responsibilities under EU laws. The role is based on-site in Woerden, Netherlands.

You will act as a SME for EO obligations, collaborate with Country Regulatory Affairs and COE functions, and support the development and maintenance of EO compliance across the region.

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 MDR.
• Fluent in English and Dutch (written and verbal).

Responsibilities

• Perform general Q&R activities in the Netherlands site, aligned with COE priorities.
• Maintain and improve QMS processes and infrastructure for compliance and business support.
• Act as Q&R SME for Economic Operator obligations across European regulations (IVDR/MDR).
• Support EO compliance processes regionally and with cross-functional partners.

Skills

Quality & Regulatory

Lead Auditor ISO9001

English & Dutch

Education

Bachelor’s degree in Life Sciences or related

Job description

Danaher Corporation is seeking a Specialist, Quality & Regulatory Affairs to support Quality and Regulatory compliance for the Netherlands and broader European operations, with emphasis on Economic Operator responsibilities under EU laws. The role is based on-site in Woerden, Netherlands.

You will act as a SME for EO obligations, collaborate with Country Regulatory Affairs and COE functions, and support the development and maintenance of EO compliance across the region.