Vice President, RA/QA

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 VP, Quality & Regulatory Affairs provides strategy and direction to ensure all Quality and Regulatory Affairs systems are established, implemented, and maintained in accordance with applicable standards for Radiometer and worldwide regulatory requirements.  The role is also responsible for ensuring that the business meets or exceeds the expectations of customers and other stakeholders in these areas.  The position will also oversee the HemoCue business.

This position reports to the Group VP, Quality, Regulatory, and Clinical Affairs and is part of the Quality and Regulatory Affairs job function located in Copenhagen, Denmark. This will be an on-site role.

Key Responsibilities:

Quality (Global Head of Quality)

• Define and lead the global quality strategy for Radiometer and HemoCue
• Ensure effective implementation of ISO 9001 and ISO 13485-based quality management systems
• Drive a strong culture of quality, compliance, and continuous improvement across the organisation
• Ensure robust processes, governance, and organisational capabilities to maintain an effective Quality Management System aligned with global regulatory requirements
• Provide leadership on quality-related matters in mergers, acquisitions, and integrations, as required
• Build strong partnerships with QA/RA/CA leaders across Danaher to leverage best practices and drive cross-business initiatives
• Serve as primary liaison with regulatory authorities and customers on quality matters, including inspections and audit responses
• Partner cross-functionally to ensure product development and manufacturing processes meet regulatory and customer expectations

Regulatory Affairs (Global Head of Regulatory Affairs)

• Lead the global Regulatory Affairs organisation to deliver best-in-class regulatory strategy and execution
• Develop and drive global regulatory strategies to enable timely market access for a diverse IVD portfolio
• Ensure strong expertise and execution across key markets, including US FDA, EU IVDR, China, and other high-growth markets
• Represent Radiometer in interactions with regulatory agencies, industry bodies, and external stakeholders globally
• Ensure compliance with applicable regulatory frameworks across design, manufacturing, and service
• Enable organisational readiness for regulatory requirements (e.g. CE-IVD, FDA 510(k), and other global submissions)

The essential requirements of the job include:

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred
• ~20+ years of relevant industry experience, including substantial leadership experience in global, matrixed organizations and managing diverse, geographically dispersed teams
• Strong expertise in Quality and Regulatory Affairs within In Vitro Diagnostics, and/or Medical Devices.
• Deep knowledge of regulatory frameworks including ISO 13485, ISO 27001, EU IVDR/MDR, NMPA and US FDA requirements (Class II or higher),
• Demonstrated success in influencing strategic business decisions and delivering value through compliant product launches
• Proven track record in building organizational capability and leading geographically dispersed teams
• Experience working in global, multicultural environments

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Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Willingness to travel globally as required (25-30%)

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

• Certification in Quality or Regulatory disciplines (e.g. CQE, CQA, RAC, CLIA Six Sigma) is an advantage

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.