EU Q&R Specialist: IVDR/MDR & EO (Netherlands)

Radiometer; Woerden; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Remote work option

Job summary

Danaher Diagnostics seeks a Specialist, Quality & Regulatory Affairs to support Netherlands and broader European operations. The role focuses on Economic Operator obligations under EU regulations and will be based on-site in Woerden with potential remote flexibility.

Requirements include a Life Sciences/Regulatory/Quality degree, ISO 9001 lead auditor certification, and fluency in English and Dutch. Travel within NL and to other EU locations is expected.

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&RA activities for the Netherlands site, aligned with COE priorities.
• Maintain and improve QMS processes to support the Commercial organization.
• Act as Q&RA SME for Economic Operator obligations across European regulations.

Skills

Regulatory Affairs

Quality Assurance

Auditing

IVDR/MDR knowledge

Education

Bachelor's degree in Life Sciences/Regulatory/Quality

Job description

Danaher Diagnostics seeks a Specialist, Quality & Regulatory Affairs to support Netherlands and broader European operations. The role focuses on Economic Operator obligations under EU regulations and will be based on-site in Woerden with potential remote flexibility.

Requirements include a Life Sciences/Regulatory/Quality degree, ISO 9001 lead auditor certification, and fluency in English and Dutch. Travel within NL and to other EU locations is expected.