Senior Manager, Regulatory Affairs

Danaher Corporation; Vista (CA); Vor Ort; USD 155.000 - 165.000; Vollzeit

Benefits dieser Stelle

Bonus eligible

Healthcare benefits

401(k) plan

Zusammenfassung

Leica Biosystems, part of Danaher, seeks a Senior Manager of Regulatory Affairs to lead global regulatory submissions for high-complexity diagnostic products, including IVDs and digital pathology. The role partners with Clinical Affairs, QA, R&D, and more to align strategies and resources.

You will drive regulatory planning, negotiate with agencies, and guide teams across regions to enable timely global commercialization.

Qualifikationen

• Bachelor’s, Master’s, or PhD in a scientific or engineering discipline.
• In-depth working knowledge of FDA and EU regulatory requirements for IVD devices.
• Extensive progressive experience supporting new product development and sustaining high-complexity diagnostic products (5+ years).
• Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k submissions.
• Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.

Aufgaben

• Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), EU IVDR Technical Files, STED).
• Collaborate globally and cross-functionally to define and execute regulatory strategies for Leica Biosystems technologies.
• Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies.
• Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations and competitive landscapes.
• Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply DBS tools to drive continuous improvement.

Jobbeschreibung

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 (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity hardware and software products including but not limited to IVDs and digital pathology in the clinical oncology environment. This individual will lead cross-functional regulatory initiatives, partnering 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 in USA).

This position reports to the Senior Director, Regulatory Affairs and is part of the Regulatory Affairs Team.

In this role, you will have the opportunity to:

• Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), EU IVDR Technical Files, STED) by defining requirements, standardizing processes, optimizing timelines, and adapting plans as needed.
• Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, QA, R&D, Program Management) to define and execute regulatory strategies for Leica Biosystems technologies
• Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies.
• Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
• Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.

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 IVD devices.
• Extensive progressive experience supporting new product development and sustaining high-complexity diagnostic products (5+ years)
• Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k submissions.
• Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.

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.
• Leads 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.

The annual salary range for this role is $155,000 – $165,000. 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 range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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.

#LI-LCS

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.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].