EU QRA Specialist: IVDR/MDR & EO Compliance

Beckman Coulter Diagnostics; Amsterdam; On-site; EUR 60,000 - 90,000; Full time

Job summary

Danaher Diagnostics is seeking a Specialist, Quality & Regulatory Affairs to support Netherlands and European operations with emphasis on Economic Operator obligations under EU regulations. The role reports to the Q&RA Manager (UK & CH) and is primarily on-site in Woerden, Netherlands.

Responsibilities include leading Q&RA activities, maintaining the QMS, and ensuring compliance with IVDR and MDR, importer/distributor duties, and EO processes.

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 (EU 2017/746) and MDR (EU 2017/745).
• 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 & Regulatory Affairs

EU Regulatory Knowledge

English

Dutch

Education

Bachelor’s degree in Life Sciences/Regulatory

Lead auditor ISO 9001

Job description

Danaher Diagnostics is seeking a Specialist, Quality & Regulatory Affairs to support Netherlands and European operations with emphasis on Economic Operator obligations under EU regulations. The role reports to the Q&RA Manager (UK & CH) and is primarily on-site in Woerden, Netherlands.

Responsibilities include leading Q&RA activities, maintaining the QMS, and ensuring compliance with IVDR and MDR, importer/distributor duties, and EO processes.