

New · posted Nov 6
Intuitive · Medical Devices
Senior Regulatory Affairs Specialist - OUS Support
- 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 provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in OUS regulated markets for complex products.
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.
- Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets
Required Knowledge, Skills and Abilities
- OUS 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.
Physical Requirements
- 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.
What you'll do
- Coordinate and manage OUS global regulatory teams for product registrations and variations.
- Assist with regulatory strategies for OUS markets.
- Advise cross-functional teams on global compliance requirements.
- Provide expert guidance in interpretation of international regulations.
- Represent regulatory affairs team in project meetings.
- Review, approve, and update project documentation.
Pay and benefits
Intuitive didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Equity
Incentives
Market-competitive compensation
Where you'll work
Sunnyvale, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sunnyvale, CAEqual 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 US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $135,000 | $143,000 | $146,500 |
Comparisons: the base pay employers published on open International Regulatory Affairs roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in International Regulatory Affairs
The general path across 10 open International Regulatory Affairs 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 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- GMP and compliance4
- Documentation and SOPs3
- Regulatory submissions3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern International Regulatory Affairs work in medical devices, each linked to the agency or standards body that publishes it.
- 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
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- 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
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- NMPAChina NMPA(official source, opens in a new tab)China's National Medical Products Administration
- TGAAustralia TGA(official source, opens in a new tab)Australia's Therapeutic Goods Administration
- ANVISABrazil ANVISA(official source, opens in a new tab)Brazil's Health Regulatory Agency
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
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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Senior Regulatory Affairs Specialist - OUS Support at Intuitive
Open until filled.


