Principal, Regulatory Affairs

**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, 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 Leica Biosystems, 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 which makes everything possible.

The **Principal, 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 partner with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).

This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on-site role.

**In this role, you will have the opportunity to**:

- Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical device and RUO products.
- Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring.
- Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance.
- Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
- Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.

**The essential requirements of the job include**:

- Bachelor’s degree in science or engineering or equivalent experience.
- Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market. Experience supporting clinical trials a plus.
- In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices.
- Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510k, PMA, and Health Canada submissions.
- Strong analytical mindset with a continuous drive for regulatory intelligence and mínimal supervision needed.

**Travel, Motor Vehicle Record & Physical/Environment Requirements**:

- Ability to travel - list specifics 15% travel, overnight, within territory or locations

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

- 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.
- Works 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.

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.

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