Senior Specialist Commercial Quality and Regulatory Affairs (w/m/d)

Senior Specialist Commercial Quality and Regulatory Affairs (w/m/d)

Join to apply for the Senior Specialist Commercial Quality and Regulatory Affairs (w/m/d) role at Beckman Coulter Diagnostics.

Reporting to the Senior Manager - Commercial Q&RA for Northern Europe, the Senior Specialist – Commercial Q&RA, Germany, Austria & the Netherlands is responsible for all Q&RA and Environmental activities to support regional commercial operations for the Danaher Diagnostics platform.

In This Role, You Will Have The Opportunity To

• Maintain, implement, and continuously improve QMS processes and infrastructure to ensure best-in-class compliance and strong business support for the Commercial organization.
• Develop, monitor, and report on key metrics to measure the performance of the Quality System.
• Drive the successful achievement of Commercial Q&RA objectives and provide regular updates on progress.
• Support the development and execution of Commercial Operations objectives for the region.
• Provide input into the EU Commercial Q&RA budget planning process.

The Essential Requirements Of The Job Include

• University degree in Science or equivalent.
• Lead Auditor certification (ISO 9001).
• Proven experience managing a certified ISO 9001 Quality Management System.
• Strong knowledge of IVDR, environmental, and related regulations.
• Demonstrated ability to manage ambiguity, influence without authority, and drive results within a global, multi-cultural, matrixed organization.
• Excellent communication skills in German and English.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel for up to 20%.

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

• Proficiency in Dutch (in addition to English and German).
• Experience collaborating with external stakeholders such as regulatory authorities, notified bodies, or industry associations.
• Hands-on experience leading or influencing without authority or supporting continuous improvement initiatives (e.g., Lean, Six Sigma, or DBS tools).

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit

#J-18808-Ljbffr