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New · posted Nov 3

Intuitive · Medical Devices

Senior Regulatory Affairs Specialist

  • 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 provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in
global regulated markets for complex products.
Essential Job Duties
• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Lead regulatory submissions, agency communications and strategy for the US and Canada for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Review, approve, and update project documentation.

What you need

Required Experience and Education

• 8+ years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education
and experience.
Required Knowledge, Skills and Abilities
• Agency negotiation and strategic planning proficiency.
• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.
• Experience with audits, submissions, and training.

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.

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, CA
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 3, 2026

Salary intelligence

How the pay compares

Senior & Principal roles in California18 roles publishing pay

Middle half $131,250 to $150,000, median $142,000

Senior & Principal roles in the US50 roles publishing pay

Middle half $117,000 to $152,625, median $141,000
Annual base pay
Annual base payLowMedianHigh
California$131,250$142,000$150,000
All US$117,000$141,000$152,625

Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 302 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Intuitive's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $92K median42 open
  2. This role

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $141K median70 open
  3. Next step

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $164K median65 open
  4. Later

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $233K median105 open
  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Regulatory Affairs, Roche Diagnostics

    $333K median20 open

Skills DNA

What this role leans on

How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesDocumentation and SOPs: 3 linesRegulatory submissions: 2 linesCollaboration and leadership: 5 linesGMPDocumentationSubmissionsTeamwork
  • Collaboration and leadership5
  • GMP and compliance3
  • Documentation and SOPs3
  • Regulatory submissions2

Company hiring pulse

Intuitive on Regulatory Jobs

30
Open roles
24
Distinct roles
5
Locations

By discipline

  • Quality13 43%
  • Regulatory11 37%
  • Clinical6 20%

By level

  • Senior & Principal19 63%
  • Associate & Specialist6 20%
  • Manager5 17%
See all 30 Intuitive roles

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Senior Regulatory Affairs Specialist at Intuitive

Open until filled.

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