Regulatory Affairs Technical Lead

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 155,000 - 262,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale seeks a senior regulatory leader to drive enterprise-wide regulatory initiatives, shape strategy, and collaborate with executives and cross-functional teams to ensure compliance and market expansion.

You will mentor regulatory professionals, oversee submissions and agency communications for the US and Canada, and lead responses to inquiries and inspections, while aligning with ML/CADe/x validation requirements.

Qualifications

• 10-12 years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience.

Responsibilities

• 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.

Skills

Regulatory strategy

Executive communication

Leadership & mentorship

Technical writing

Cross-functional collaboration

ML/CADe/x validation

FDA clearances

Education

Bachelor's degree in a relevant discipline

Job description

Company Description

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.

Job Description

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.

Essential Job Duties

• 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.

Qualifications

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

Working Conditions

• Not applicable

Additional Information

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.

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.

Mandatory Notices

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:

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).

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.

Base Compensation Range Region 1: $182,000 USD - $262,000 USD

Base Compensation Range Region 2: $154,700 USD - $222,700 USD

Shift: Day

Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.