

New · posted Nov 6
Intuitive · Medical Devices
Regulatory Affairs Technical Lead
- Sunnyvale, CA
- On-site
- Full-time
- Senior & Principal
The role
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.
If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.
Primary Function of Position
This role leads regulatory initiatives for enterprise-wide products or platforms, drives regulatory strategy, and collaborates with executive and cross-functional teams for compliance and market expansion.
What you need
Required Education and Training
- 10-12 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.
Required Skills and Experience
- Mastery of global regulatory affairs, strategy, and submission expertise.
- Executive-level communication and negotiation skills.
- Strong leadership and mentorship for regulatory teams.
- Advanced technical writing, analytics, and project management.
- Track record collaborating across functions and with agencies worldwide.
- Experience with ML/CADe/x validation and global regulatory requirements
- Experience gaining FDA clearances for ML, CADe/x, and complex medical devices
What you'll do
- Develop global regulatory strategies for complex product portfolios.
- Advise executives and teams on regulatory risks, trends, and compliance options.
- Lead complex regulatory strategy, regulatory submissions, agency communications for the US and Canada.
- Lead response to major regulatory agency inquiries, inspections, and audits.
- Develop training materials on new regulations and regulatory changes.
- Review, approve and update project documentation.
- Track and analyze global regulatory changes and their impact on the business.
- Mentor regulatory team members.
- Coordinate with OUS global regulatory teams for product registrations and variations.
- Provide metrics, dashboards, and executive communication on regulatory efforts.
- Represent company in industry and regulatory forums.
Pay and benefits
Intuitive didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Market-competitive compensation
Incentives
Equity
Where you'll work
Sunnyvale, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sunnyvale, CAWorking conditions
- Not applicable
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
Accommodation & Accessibility Notice:
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
Equal opportunity, accessibility and legal noticesIntuitive's statements, word for word
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [email protected].
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $150,000 | $159,750 | $174,750 |
Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 89 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Intuitive's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership14
- GMP and compliance4
- Regulatory submissions4
- Documentation and SOPs3
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, each linked to the agency or standards body that publishes it.
- 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
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- 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)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- 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
Company hiring pulse
Intuitive on Regulatory Jobs
- 34
- Open roles
- 34
- Distinct roles
- 5
- Locations
By discipline
- Quality15 42%
- Regulatory12 33%
- Clinical9 25%
By level
- Senior & Principal22 61%
- Manager8 22%
- Associate & Specialist6 17%
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Regulatory Affairs Technical Lead at Intuitive
Open until filled.


