Senior Manager, Regulatory Affairs

Position Summary

The Sr. Manager Regulatory Affairs for the Digital Portfolio leads regulatory strategy and execution for software-driven products including software as a medical device (SaMD) software in a medical device (SiMD) cloud and connected applications data and analytics tools and AI/ML-enabled features that support surgical care. This leader builds and manages a team of regulatory professionals and serves as the senior regulatory voice to Digital R&D Quality Clinical Cybersecurity Privacy Legal and Commercial partners. The role ensures that digital innovations reach customers quickly compliantly and sustainably across global markets.

Key Responsibilities

Regulatory Strategy and Leadership

Develop and execute global regulatory strategies for digital products aligned with business priorities and product roadmaps.

Determine device classification qualification and pathway for software functions including whether features meet the definition of a medical device or fall under enforcement discretion.

Advise cross-functional leaders on regulatory risk timelines and trade-offs early in the design process.

Represent Regulatory Affairs on digital product core teams and governance forums.

Manage the regulatory assessment and ongoing oversight of the non-medical device portfolio of products including determining non-device status maintaining supporting rationale and documentation and ensuring claims labeling and software updates do not change a products regulatory status.

Submissions and Market Authorization

Lead preparation review and submission of 510(k) De Novo and other premarket submissions.

Own regulatory strategy for software change management including determining when changes require new submissions and leveraging Predetermined Change Control Plans (PCCPs) where appropriate.

Lead interactions with FDA including pre-submission meetings and responses to deficiency requests.

Software AI/ML and Cybersecurity Expertise

Apply FDA software guidance and consensus standards (e.g. IEC 62304 IEC 82304-1 IEC 62366-1 ISO 14971 IEC) to digital product development and documentation.

Guide regulatory strategy for AI/ML-enabled functionality including model transparency validation data management bias assessment lifecycle monitoring and change control; monitor evolving requirements such as the EU AI Act.

Ensure premarket cybersecurity expectations are met (e.g. FD&C Act Section 524B SBOM threat modeling vulnerability management postmarket plans) in partnership with Product Security.

Partner with Privacy and Legal on the interplay between medical device regulation and data protection requirements (e.g. HIPAA GDPR).

Lifecycle and Compliance

Review and approve design changes labeling instructions for use and promotional/digital content for regulatory compliance.

Support postmarket activities including complaint and adverse event assessment field actions and regulatory reporting for software issues.

Support inspections and audits (FDA MDSAP) and contribute to quality system procedures for software and digital development.

Maintain regulatory intelligence on digital health SaMD AI and cybersecurity regulations; assess impact and drive proactive readiness.

People Leadership

Recruit develop coach and retain a high-performing team; set clear goals allocate work and foster an inclusive collaborative culture.

Build scalable processes templates and tools that improve submission quality and speed.

Manage department priorities resourcing and budget for the digital portfolio.

Qualifications :

Qualifications

Required

Bachelors degree in engineering life sciences computer science or a related technical field.

8 years of regulatory affairs experience in medical devices including 3 years of direct experience with software SaMD or digital health products.

Demonstrated success leading US premarket submissions for software-containing devices.

Working knowledge of FDA regulations (21 CFR 820 / QMSR 21 CFR Part 11) EU MDR and software lifecycle and cybersecurity requirements.

3 years of experience leading or managing people or cross-functional project teams.

Strong written and verbal communication skills with proven ability to influence senior stakeholders and regulators.

Preferred

Masters degree or advanced degree in a relevant field.

Experience with AI/ML-enabled medical devices PCCPs and cloud-based or connected platforms.

Experience with robotic-assisted surgery surgical data or enterprise-scale digital ecosystems.

Regulatory Affairs Certification (RAC) or equivalent.

Experience with global markets beyond the US and EU and direct health authority engagement.

Core Competencies

Strategic thinking: Translates evolving regulation into practical business-aligned strategy.

Technical fluency: Engages credibly with software engineers data scientists and security experts.

Influence and collaboration: Builds trust across functions and drives decisions without relying on authority.

Agility: Thrives in fast-moving iterative development environments while maintaining compliance.

Leadership: Develops talent and holds a high bar for quality and integrity.

Working Conditions

Position is based at Sunnyvale CA. Travel up to 20% for health authority meetings site visits and conferences.

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 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