Senior Quality and Regulatory Affairs Specialist — EU EO

Beckman Coulter Diagnostics

Utrecht

Hybrid

EUR 70,000 - 100,000

Full time

14 days+

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Job summary

Danaher Diagnostics seeks a Specialist in Quality & Regulatory Affairs to support the Netherlands site and broader European operations. The role focuses on Economic Operator responsibilities under EU regulations, with emphasis on IVDR and MDR, and requires fluency in English and Dutch.

Travel across the Netherlands and occasional EU travel are involved, with remote work options available. The position reports to the QRA Manager (UK & CH) and is primarily on-site in Woerden, NL, within a dynamic,

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 QRA activities in support of the Netherlands site.
Maintain, implement, and improve QMS processes and infrastructure for compliance and business support.
Act as a QRA SME for Economic Operator obligations across European regulations (IVDR/MDR).
Support compliance with Importer and Distributor obligations (Articles 13 and 14 IVDR/MDR).