New · posted Nov 4
Danaher · Medical Devices
Senior Manager, Regulatory Affairs
- Vista, CA
- On-site
- Full-time
- Manager
The role
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 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.
What you need
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 innice to have
- 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.
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.
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.
The U.S. EEO posters are available here.
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.
What you'll do
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.
Pay and benefits
$155,000 – $165,000 a year
Employer providedThe 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.
Paid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Bonus/incentive pay
Where you'll work
Vista, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Vista, CAEqual opportunity, accessibility and legal noticesDanaher's statements, word for word
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 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 [email protected].
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Manager roles in California5 roles publishing pay
Manager roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $165,000 |
| California (middle half) | $160,000 | $181,000 | $181,000 |
| All US (middle half) | $145,250 | $162,500 | $181,000 |
This role: Danaher's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 73 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions4
- Documentation and SOPs3
- Quality systems and risk2
- GMP and compliance1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices RegulationNamed in the posting
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
Company hiring pulse
Danaher on Regulatory Jobs
- 60
- Open roles
- 51
- Distinct roles
- 20
- Locations
By discipline
- Quality51 85%
- Regulatory6 10%
- Clinical3 5%
By level
- Senior & Principal28 47%
- Associate & Specialist22 37%
- Manager8 13%
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Senior Manager, Regulatory Affairs at Danaher
Open until filled. $155K–$165K a year, employer provided.