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New · posted Nov 6

Intuitive · Medical Devices

Regulatory Affairs Technical Lead

  • Sunnyvale, CA
  • On-site
  • Full-time
  • Senior & Principal
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EmploymentFull-time
DeadlineOpen until filled

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)

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Working 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

Middle half $150,000 to $174,750, median $159,750
Annual base pay
Annual base payLowMedianHigh
All US$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.

  1. One step back

    Associate & Specialist

    Often: Associate Consultant, Regulatory Science and Strategy · Spring 2027 Co-op, Global Regulatory Affairs

  2. This role

    Senior & Principal

    Often: Principal Regulatory Affairs Specialist · Regulatory Affairs Strategist, Globalization

    $160K median10 open
  3. Next step

    Manager

    Often: Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada · Manager, Regulatory Affairs Strategy

    $160K median21 open
  4. Later

    Director

    Often: Director, RA Global Regulatory Strategy · Associate Director, Regulatory Affairs Strategy

    $252K median48 open
  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Technical Regulatory & Quality

    $333K median8 open

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.

GMP and compliance: 4 linesDocumentation and SOPs: 3 linesValidation and qualification: 1 lineRegulatory submissions: 4 linesCollaboration and leadership: 14 linesGMPDocumentationValidationSubmissionsTeamwork
  • 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.

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%
See all 34 Intuitive roles

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Regulatory Affairs Technical Lead at Intuitive

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