Senior Director, Regulatory Affairs

As Senior Director, Regulatory Affairs, you will be at the forefront of shaping and executing Radiometer’s global regulatory strategy, driving innovation, enabling market access, and ensuring compliance across international markets through strategic leadership of cross-functional teams.

You will be a key member of the Quality & Regulatory Affairs leadership team, reporting to the Vice President, QARA, and play a pivotal role in enabling Radiometer’s mission to bring trusted, life-saving diagnostics to patients around the world.

In this role, you will:

• Develop and execute global regulatory strategies that align with business objectives, anticipate emerging requirements, and accelerate approvals across global markets.
• Lead and mentor a high-performing global Regulatory Affairs team, fostering accountability, collaboration, and building organizational capability through talent development.
• Serve as the strategic interface with global health authorities (including FDA, EU Notified Bodies, and other major agencies) to accelerate approvals, ensure compliance, and guide product development and commercialization. 
• Position RA as a growth enabler, ensuring the business earns customer trust and exceeds stakeholder expectations by aligning regulatory strategies with business objectives. Partner with R&D, Product management, Clinical, and Commercial teams to guide product development from concept through commercialization and post-market surveillance.
• Drive regulatory innovation and process optimization by leveraging data, technology, and DBS principles to enhance regulatory effectiveness, strengthen global RA processes, ensure compliance, and foster a culture of quality and continuous improvement across QMS interfaces.
• Represent Radiometer externally to shape regulatory policy and advocacy in partnership with trade associations and regulatory bodies.

The Essential Requirements:

• Demonstrated senior leadership experience managing direct reports and cross-functional teams across geographies, with a proven track record of coaching and developing high-performing talent.
• Ability to set strategic goals and drive execution, including prioritization of regulatory deliverables, acceleration of timelines, and measurable impact on compliance and time-to-market, including interactions with FDA, EU notified bodies, and other major health authorities.
• Proven success in leading global regulatory strategy and submissions for complex medical device or diagnostic products, including FDA, EU Notified Bodies, and international authorities, while translating regulatory intelligence into forward-looking strategies that support innovation, market access, and business growth.
• Demonstrated ability to lead or collaborate closely with Quality functions, ensuring effective QMS execution, regulatory compliance, RA process effectiveness, audits, inspections, and overall readiness across both Quality and Regulatory Affairs.
• Proven experience in driving organizational or process transformation to improve operational efficiency and compliance scalability.
• Advanced degree in a scientific, engineering, or regulatory discipline, or equivalent relevant experience.

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

• Experience with medical devices (MDs) is a plus
• Prior experience leading a Quality function, including oversight of QMS, audits, and compliance initiatives.
• Experience partnering with Clinical Affairs to support evidence generation for product claims or submissions.

We review applications on an ongoing basis and look forward to hearing from you. Submit your application today – we’re excited to learn more about you!

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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.