Senior Specialist, Quality & Regulatory Affairs

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 livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Were accelerating the development of cutting-edge diagnostics to solve some of the worlds most pressing health challenges. Across our diagnostics operating companieswe are drivinginnovationthroughpartnerships with top academic institutions and leading players in biopharma and translational bringing the best minds together toaccelerateinnovation and unlock the full potential of the latest scientific advances. Together were expanding access to precision diagnostics for millions of people worldwide - and were 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 were improving treatment options and saving lives.

Learn about theDanaher Business Systemwhich makes everything possible.

The Specialist Quality & Regulatory Affairs is 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:

• Bachelors 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 drivers 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 crossfunctionally and with external partners or suppliers.

WithinDanaherDiagnosticsweoffer a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.

WithinDanaherDiagnosticswe 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 workingwithinDanaherDiagnosticscan provide.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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