Senior Manager, Regulatory Affairs

Radiometer; Vista (CA); On-site; USD 155,000 - 165,000; Full time

Benefits offered by this job

Bonus eligibility

Comprehensive benefits package

401(k)

Job summary

Leica Biosystems, a Danaher company, seeks a Regulatory Affairs leader to drive global submissions and regulatory strategies for high‑risk diagnostic products. You will collaborate across Clinical Affairs, QA, R&D and Program Management to align plans, budgets, and timelines, while engaging regulators to secure approvals.

The role requires 5+ years in regulatory affairs for diagnostics, with FDA/EU IVDR experience and strong cross‑functional leadership. Travel ~15% is expected.

Qualifications

• 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.
• 5+ years of progressive experience in regulatory affairs for diagnostic products (incl. 510(k)).
• Experience supporting clinical trials is a plus; global submissions expertise required.

Responsibilities

• Lead a team responsible for global regulatory submissions (510(k), EU IVDR Technical Files, STED) by defining requirements and timelines.
• Collaborate with Clinical Affairs, QA, R&D and others to define regulatory strategies for technologies.
• Provide regulatory input for program planning, budgets, and timelines; align with partners on study designs.
• Engage with global regulatory agencies to achieve product clearance/approval and monitor evolving rules.

Skills

Regulatory leadership

Global submissions

FDA/EU IVDR

Cross-functional collaboration

Regulatory strategy

Negotiation with regulators

Project planning

Education

Bachelor/Master/PhD in science or engineering

Job description

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.

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.

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 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.

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 modelling 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.

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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.

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