Senior Specialist, Quality & Regulatory Affairs

Beckman Coulter Diagnostics; Zwolle; On-site; EUR 70,000 - 100,000; Full time

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.

Skills

QRA knowledge

EU regulations

Auditing skills

English & Dutch fluency

Education

Bachelor's degree in Life Sciences Regulatory Affairs Quality or related

Tools

ISO 9001 Lead Auditor

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. We’re accelerating the development of cutting‑edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide—and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible.

Specialist, Quality & Regulatory Affairs

Responsible for supporting Quality and Regulatory compliance activities for the Netherlands and broader European operations, with a particular focus on Economic Operator (EO) responsibilities under applicable EU legislation. This position reports to the Quality and Regulatory Affairs Manager (UK & CH) and will primarily be an on‑site role located in Woerden, Netherlands.

In This Role, You Will Have The Opportunity To

• 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)
  • 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.

The Essential Requirements Of The Job Include

• 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)

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel – including within the Netherlands and occasional travel to other EU locations
• Must have a valid driver’s license with an acceptable driving record

It would be a plus if you also possess previous experience in

• Supporting or interacting with Economic Operator obligations (Importer, Distributor, AR, or equivalent roles)
• Experience working cross‑functionally and with external partners or suppliers.

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.