Senior Specialist Commercial Quality and Regulatory Affairs

Vor 3 Tagen

DEU Krefeld Dusseldorf Multiple OpCo, Deutschland Danaher Vollzeit

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

  • Pre Market Quality and Regulatory Specialist

    vor 2 Wochen

    DEU - Bonn, Deutschland Dedalus Group Vollzeit 43.500 € - 83.000 € pro Jahr

    Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable?Join our TeamWe are looking for you, located in Bonn (Hybrid) as aPre-Market Quality and Regulatory Specialist (m/f/d)Your tasks:Ensuring process adherence for the pre-market proceduresCompleteness of design history files and regulatory submissionsRegulatory...

  • Food Contact and Regulatory Affairs Supervisor

    Vor 7 Tagen

    DEU - Bodelshausen Plant, Deutschland PPG Vollzeit 60.000 € - 90.000 € pro Jahr

    PPG: WE PROTECT AND BEAUTIFY THE WORLDAt PPG, we work every day to develop and deliver the paints, coatings, and materials that our customers have trusted for more than 140 years. Through dedication and creativity, we solve our customers' biggest challenges, collaborating closely to find the right path forward. With headquarters in Pittsburgh, we operate and...

  • Supplier Quality Specialist

    vor 2 Wochen

    DEU - Munich, Germany Boeing Vollzeit 50.000 € - 80.000 € pro Jahr

    Supplier Quality Specialist (Supplier Quality Systems)Company:Boeing Deutschland GmbH - BDGBoeing Germany is hiring for a Supplier Quality Specialist - based in the Munich (preferred) or Frankfurt area."Position Responsibilities:Accountable for the conformity of our suppliers' delivered parts.Accountable for our suppliers' Quality Management System...

  • Director, Medical Affairs

    Vor 7 Tagen

    Greater Dusseldorf Area, Deutschland Cepheid Vollzeit 92.000 € - 150.000 € pro Jahr

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

  • Customer Quality Specialist

    vor 21 Stunden

    Krefeld, Nordrhein-Westfalen, Deutschland Norm Fasteners Germany Vollzeit

    About Us:As Norm Fasteners, we are proud to be the leading fastener manufacturer in Turkey with over 50 years of experience and a team of more than 4,000 highly qualified employees. Our innovative R&D center, experienced engineers, high production capacity, and advanced technology make us a reliable partner in the industry. We operate 20 production...

  • Quality Coordinator

    Vor 3 Tagen

    Krefeld, Nordrhein-Westfalen, Deutschland UL Solutions External Career Site Vollzeit

    We are looking for a Quality Coordinator (m/f/i) to join our Laboratory in Krefeld to support and enhance our Quality Management System (QMS) in compliance with industry standards, regulations and requirements. The role involves ensuring accreditation, managing quality processes, and driving continuous improvement. The ideal candidate will work closely with...

  • (Senior) Project Engineer Wind

    Vor 7 Tagen

    Dusseldorf, Deutschland Statkraft Vollzeit

    Company DescriptionStatkraft has been making clean energy possible for over a century. Unrivaled pioneering spirit and a strong commitment towards a more sustainable future. That's what we offer. Today, we are Europe's largest renewable energy producer and employ more than 7.000 colleagues in 20+ countries around the world. Our vision is clear - to renew the...

  • Quality Coordinator

    Vor 3 Tagen

    Krefeld, Nordrhein-Westfalen, Deutschland UL Solutions Vollzeit

    DescriptionWe are looking for a Quality Coordinator (m/f/i) to join our Laboratory in Krefeld to support and enhance our Quality Management System (QMS) in compliance with industry standards, regulations and requirements. The role involves ensuring accreditation, managing quality processes, and driving continuous improvement. The ideal candidate will work...

  • Quality Coordinator

    vor 2 Wochen

    Krefeld, Nordrhein-Westfalen, Deutschland UL Solutions Vollzeit 45.000 € - 65.000 € pro Jahr

    Job DescriptionWe are looking for aQuality Coordinator (m/f/i)to join our Laboratory in Krefeld to support and enhance our Quality Management System (QMS) in compliance with industry standards, regulations and requirements. The role involves ensuring accreditation, managing quality processes, and driving continuous improvement. The ideal candidate will work...

  • R&D Engineer

    vor 19 Stunden

    DEU - Duesseldorf - Multiple OpCo, Deutschland Hach Vollzeit

    Imagine yourself… Working in a commercial R&D engineering environment on complex water analysis equipment combining chemical / mechanical / electrical / software components (i.e., analysers, sensors, optical measurement, etc).Utilizing your extended years of instrument development experience in physics, optics, temperature control, fluid dynamics,...