Regulatory Affairs Technical Lead

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 bachelors 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.

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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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

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.

Remote Work :

No

Employment Type :

Full-time