Senior Manager, Regulatory Affairs

Danaher Corporation; Newcastle upon Tyne; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading healthcare technology firm is seeking a Senior Manager in Regulatory Affairs to develop and execute global regulatory strategies for complex diagnostics. The role involves leading a team, collaborating cross-functionally, and engaging with regulatory agencies to ensure product approvals. Candidates must have a scientific background and in-depth knowledge of FDA and EU regulations. This position is on-site in Newcastle upon Tyne.

Benefits

Comprehensive benefits programs

Qualifications

• 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.
• Experience supporting clinical trials is a plus.

Responsibilities

• Lead a team responsible for developing and maintaining regulatory submissions.
• Collaborate cross-functionally to execute regulatory strategies.
• Provide regulatory input for program planning, including resource needs and budgets.
• Engage with global regulatory agencies for product clearance/approval.
• Share regulatory expertise across teams and apply continuous improvement tools.

Job description

Overview

The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high‑complexity diagnostics, including but not limited to IVDs, Companion Diagnostics, and digital pathology in the clinical oncology space. This individual will lead cross‑functional regulatory initiatives, partnering with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs, Performance Study Applications, EU IVDR Technical Files, and 510(k) and PMA submissions in the USA). This position reports to the Senior Director, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK. It is an on‑site role.

Responsibilities

• Lead a team of Regulatory Affairs Professionals responsible for developing, authoring, and maintaining global regulatory submissions (e.g., 510(k), PMA, EU IVDR Technical Files, STED), 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.

Qualifications

• 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 510(k) and PMA submissions.
• Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.

Preferred Qualifications

• 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 judgment to influence and lead through change.

Travel & Physical Requirements

Ability to travel – approximately 15% travel, overnight, within territory or locations. (No specific motor vehicle record required.)

About Us

At Leica Biosystems, 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.

We’re not just shaping the future of cancer diagnostics—we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next‑generation, life‑changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

Leica Biosystems, 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. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home).

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.