Senior Manager, Regulatory Affairs

Master's 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.

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.

Apply FDA software guidance and consensus standards (e.g., IEC 62304, IEC 82304-1, IEC 62366-1, ISO 14971, IEC 81001-5-1) 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).

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.

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.

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

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.

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:

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.