Senior Principal, Regulatory Affairs - Companion Diagnostics, Boston

Senior Principal, Regulatory Affairs - Companion Diagnostics

18 Days Old

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.

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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 commercialization 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 organization 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.
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 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
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.

The salary range for this role is $200k - $240k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.

This job is also eligible for bonus/incentive pay.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law

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.

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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.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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Location:: Boston

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