Senior Manager, Regulatory Affairs

Be among the first 25 applicants. Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, we’re united by a shared commitment to innovate for tangible impact and to turn ideas into impact – innovating at the speed of life. Our mission is to advance cancer diagnostics and improve lives, empowering clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. You’ll be part of a diverse, collaborative global community focused on making every moment matter in cancer care.

Learn about the Danaher Business System which makes everything possible.

• Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU IVDR Technical Files, STED) by defining requirements, standardizing processes, optimizing timelines, and adapting plans as needed.
• Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, QA, R&D, Program Management) to define and execute regulatory strategies for Leica Biosystems technologies in cancer diagnostics, IVD, and Companion Diagnostics markets.
• Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies.
• Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
• Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.

• Bachelor’s, Master’s, or PhD in a scientific or engineering discipline.
• In-depth working knowledge of FDA and EU regulatory requirements for IVD devices.
• Extensive progressive experience supporting new product development and sustaining high-complexity diagnostic products.
• Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k and PMA submissions.
• Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.

• Ability to travel – 15% travel, overnight, within territory or locations.

• Applies deep regulatory expertise to the development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
• Leads effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
• Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgement to influence and lead through change.

Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Check out our benefits at Danaher Benefits Info. For more information, visit www.danaher.com.

Newcastle Upon Tyne, England, United Kingdom