EU Q&R Specialist: IVDR/MDR & EO Compliance

Beckman Coulter Diagnostics

Zwolle

On-site

EUR 70,000 - 100,000

Full time

14 days+

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Job summary

Danaher Diagnostics in Woerden, Netherlands, is seeking a Specialist in Quality & Regulatory Affairs to support QRA activities and EO obligations across Europe. The role is on-site in the Netherlands with potential remote flexibility and travel within the EU as needed.

Key requirements include a life sciences/regulatory degree, experience in QA/RA for medical devices/IVD, and fluency in English and Dutch. The position emphasizes EU regulatory knowledge and cross-functional collaboration within

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 in support of the Netherlands site, aligned with COE priorities.
Maintain and improve QMS processes to ensure compliance and business support.
Act as Q&RA SME for Economic Operator obligations across European regulations (IVDR/MDR).
Support Importer and Distributor obligations and EO compliance processes.