Senior Regulatory Specialist I

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.

The Senior Regulatory Affairs Specialist I is responsible for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I will work closely with the cross-functional design and development team to support both IVD medical device and Research Use Only (RUO) product development and sustainment.

This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Vista CA and will be fully remote.

In this role, you will have the opportunity to:

• Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and Technical File authoring.

• Provide regulatory guidance on product labeling, marketing materials, and product changes to ensure compliance across IVD and RUO products.
• Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
• Engage with regulatory authorities (e.g., FDA, Health Canada) and support external audits and inspections.
• Lead regulatory assessments and communications to support product lifecycle management and market access.

The essential requirements of the job include:

• 5+ years of regulatory experience in IVD medical devices, with a Bachelor’s, Master’s, or PhD, or equivalent work experience.
• Skilled in technical writing and regulatory documentation, including SOPs, CE Marking, and IVDR (EU 2017/746) compliance.
• Experienced in product development and lifecycle support, including design, registration, and change assessments.
• Proven ability to lead small projects and interact directly with global regulatory authorities and government agencies.
• Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – list specifics 10% travel, overnight, within territory or locations

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

• Familiarity with regulatory tools and systems, including eQMS platforms (e.g., IQVIA), EUDAMED, and the FDA eSTAR and Customer Communication Portal.
• Experience supporting audits and compliance, including MDSAP audits and performing gap assessments against standards and regulations.
• Knowledge of CE Marking processes, including for non-medical devices.

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.

The annual salary range for this role is $95,000-130,000. 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 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.

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.

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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.