Overview 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 united by a commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. 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, “Advancing Cancer Diagnostics, Improving Lives,” drives our work as a global leader with a comprehensive portfolio from biopsy to diagnosis. We empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. You’ll join a diverse, collaborative global community that inspires growth and impact. Learn about the Danaher Business System and how it enables our work. Role 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 will provide oversight and lead global submission work in support of CDx trials and product commercialization across multiple regions (e.g., IDEs; Performance Study Applications; EU IVDR targeted failures, and 510(k)/PMA in the USA). You will mentor the organization in these activities and collaborate with BioPharma partners to develop and deploy CDx regulatory strategies. You will engage with global regulatory agencies and steer regulatory strategy for new product development and strategic initiatives, ensuring smooth global commercialization and compliance. This position reports to the Director, Regulatory Affairs and is part of Global Regulatory Affairs and will be fully remote. Responsibilities 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; update internal procedures to reflect evolving US and international regulations. Assess the impacts of relevant drug and diagnostic regulations on 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 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, with in-depth knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Additional regions are a bonus but not core. Extensive experience with cross-functional teams developing companion diagnostics and devices, including regulatory strategies for high-complexity diagnostic products (510(k), PMA). Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Applications. Experience coordinating regulatory strategies with clinical plans and marketing objectives and communicating strategy, issues, and risks to regulatory leadership. Understanding of the global regulatory strategy role in drug and device development and commercialization. Travel Travel approximately 25%. Preferred Experience Applying advanced regulatory expertise to global development and commercialization of complex, high-risk products. Leading cross-functional teams in a matrixed environment with timely decision-making and stakeholder alignment. Experience with drug development and drug regulatory procedures. Benefits and Compensation Leica Biosystems, a Danaher operating company, offers a comprehensive benefits program. Check Danaher Benefits Info for details. Salary range: $200k — $240k. This range is the expected compensation at posting time. This role is eligible for bonus/incentive pay. Note: Compensation details are subject to change and earned, vested, and determinable according to company policy and applicable law. Work Arrangement We support flexible, remote working arrangements for eligible roles. This position is eligible for remote work from your home; further information will be provided by the interview team.
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