Senior Principal, Regulatory Affairs - Companion Diagnostics

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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.

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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 work with Biopharma partners to develop and deploy CDx regulatory strategies. In this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By guiding regulatory activities, this role ensures smooth global commercialization and compliance, driving innovation and excellence in the Biopharma sector.

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.

• Innovate, communicate and execute strategic regulatory plans, drive results independently and in a matrix-team environment, willing to solve complex problems to meet business obligations on time.

• Maintain regulatory intelligence 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 and EU Performance Study Application submissions .

• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required

• Excellent collaborator within complex multi-stakeholder programs, with a proven ability to evaluate and communicate regulatory risks and business impacts, adapting strategies and resource allocation in response to evolving information and priorities.

• Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.

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

• Ability to travel 25%

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

• Applying advanced regulatory expertise to support the global development and commercialization of complex, high-risk products, with a focus on both immediate challenges and long-term strategic outcomes.

• Leading cross-functional teams in a matrixed environment, ensuring timely decision-making, issue resolution, and alignment across global and culturally diverse stakeholders.

• Experience with drug development and drug regulatory procedures.

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 .

At Leica Biosystems, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.

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.

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