Regulatory Affairs jobs in United States

Bring more to life.

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

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work 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.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

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 www.danaher.com .