About the role
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 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.
At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll 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:
Master’s 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 ISO 13485, 21 CFR 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 it’s a health care program or paid time off, our programs contribute to life beyond the job.
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.
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Originally posted on Himalayas