Senior Principal, Regulatory Affairs - Companion Diagnostics

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 Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and submissions to support product commercialisation in multiple regions (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA) and will mentor the organisation in these key activities. The Senior Principal Regulatory Affairs will collaborate cross-functionally and with internal and external business partners, including Pharmaceutical partners and global regulatory agencies on new product development and strategic initiatives to lead the regulatory activities for global commercialization. 

This position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote.

In this role, you will have the opportunity to:

• Lead regulatory strategy and execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards.

• Maintain regulatory intelligence and execute regulatory plans, and ensure internal procedures are updated to reflect evolving US and international regulations.

• Assess the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products

• Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals.

• Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to, business and clinical goals.

• Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings. 

The essential requirements of the job include:

• Bachelor’s, Master’s, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are a bonus but not a core requirement.

• Extensive experience working with cross functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions.

• Proven track record supporting new product development and complex clinical trials, including IDE approvals