EU Q&RA Specialist — IVDR/MDR & EO (Remote)

Beckman Coulter Diagnostics; Eindhoven; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Danaher Diagnostics is seeking a Specialist, Quality & Regulatory Affairs to support the Netherlands site and European operations, located on-site in Woerden, NL. The role focuses on Economic Operator responsibilities under EU law, with primary emphasis on IVDR/MDR and EO compliance.

You will perform Q&RA activities, maintain QMS processes, and act as SME for EO obligations across EU regulations. Travel within NL and EU is expected; remote work arrangements may be available for eligible roles.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, or related discipline.
• Experience in Quality and/or Regulatory Affairs within Medical Device or IVD.
• 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.
• Maintain and improve QMS processes to support compliance.
• Act as SME for Economic Operator obligations across EU regulations.
• Support importer and distributor obligations in EU regulations.
• Support the development and maintenance of EO compliance processes.

Skills

Quality & Regulatory Affairs

Regulatory compliance

Auditing

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, or related discipline

Job description

Danaher Diagnostics is seeking a Specialist, Quality & Regulatory Affairs to support the Netherlands site and European operations, located on-site in Woerden, NL. The role focuses on Economic Operator responsibilities under EU law, with primary emphasis on IVDR/MDR and EO compliance.

You will perform Q&RA activities, maintain QMS processes, and act as SME for EO obligations across EU regulations. Travel within NL and EU is expected; remote work arrangements may be available for eligible roles.