Senior Manager, Technical Service & Compliance

Bring more to life.

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

At Radiometer one of Danahers 15 operating companies our work 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.

At Radiometer life comes first. Our vision is to improve global healthcare with reliable fast and easy patient diagnoses. Were a team that celebrates diverse ideas and continuous improvement. Here youll find a place to grow and make a real impact with your unique perspective driving us forward in improving patient care. At Radiometer our vision is to improve global healthcare with reliable fast and easy patient diagnoses.

Learn about the Danaher Business System which makes everything possible.

The Senior Manager Technical Service & Compliance is responsible for leading global service compliance strategy ensuring adherence to regulatory quality and internal standards across service operations. This role drives governance audit readiness and continuous improvement to mitigate risk and enhance operational excellence.

This position reports to the Director Global Technical Service and is part of the Global Service located in Europe and will be a remote role.

In this role you will have the opportunity to:

• Lead global service compliance strategy and execution ensuring alignment with regulatory and quality standards

• Own and maintain the Service QMS driving consistent implementation across regions

• Manage CAPA processes field actions and compliance investigations in line with regulatory requirements

• Ensure audit and inspection readiness; lead internal and external quality system audits

• Own and improve the QCT process (with focus on QCT1) ensuring timely and compliant triage

• Develop and deliver quality insights driving data-based decision-making and continuous improvement

• Serve as the key compliance interface across Service R&D Regulatory Affairs and Post-Market Surveillance to ensure end-to-end issue resolution

The essential requirements of the job include:

• Masters degree within Regulatory Engineering STEM or Commercial

• 10 years of progressive experience in quality compliance or service operations within the medical device industry or related regulated healthcare sector

• Deep understanding of ISOCFR Part 820 MDR and other global regulatory frameworks

• Experience in leading CAPA systems audit processes field action coordination and compliance investigations within a regulated environment

• Hands-on experience in Data Analytics and Dashboards through PowerBI and advanced Excel

• Proven leadership capability with strong stakeholder communication and the ability to drive change management initiatives

• Experience in designing and implementing scalable compliance processes with demonstrated impact on audit outcomes and customer satisfaction metrics

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 20% including international travel as required

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

• Experience in diagnostics medical devices or life sciences industry

• Certification in quality/compliance (e.g. Six Sigma Black Belt ISO Lead Auditor)

• Exposure to global service network operations

Radiometer a Danaher operating company offers 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.

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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