EU Quality & Regulatory Specialist - IVDR/MDR, EO, Remote

Beckman Coulter Diagnostics; Woerden; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Benefits package

Job summary

Beckman Coulter Diagnostics in Woerden, Netherlands, is seeking a Specialist, Quality & Regulatory Affairs to support Netherlands and broader European operations, with a focus on Economic Operator responsibilities under EU legislation.

You will act as a Q&RA SME for EO obligations across European regulations (IVDR/MDR), support Importer and Distributor obligations, and help develop, implement and maintain sustainable compliance processes across the region.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Experience in Quality and/or Regulatory Affairs within Medical Device/IVD.
• Lead auditor certification (ISO 9001) and knowledge of EU regulations (IVDR/MDR).
• Fluent in English and Dutch (written and verbal).

Responsibilities

• Support general Q&RA activities for the Netherlands/Europe.
• Maintain and improve QMS processes for compliance and business support.
• Act as SME for Economic Operator obligations across EU regulations (IVDR/MDR).
• Support Importer and Distributor obligations in collaboration with Country Regulatory Affairs.

Skills

Fluent English

Fluent Dutch

Education

Bachelor’s degree in Life Sciences

Lead auditor ISO 9001

Job description

Beckman Coulter Diagnostics in Woerden, Netherlands, is seeking a Specialist, Quality & Regulatory Affairs to support Netherlands and broader European operations, with a focus on Economic Operator responsibilities under EU legislation.

You will act as a Q&RA SME for EO obligations across European regulations (IVDR/MDR), support Importer and Distributor obligations, and help develop, implement and maintain sustainable compliance processes across the region.