Senior Manager, Regulatory Affairs

Intuitive•Sunnyvale, CA

4d•Onsite

About The Position

The Senior Manager, Regulatory Affairs for the Digital Portfolio leads regulatory strategy and execution for software-driven products, including SaMD, SiMD, cloud and connected applications, data and analytics tools, and AI/ML-enabled features supporting surgical care. The role builds and manages a regulatory team and serves as the senior regulatory voice to Digital, R&D, Quality, Clinical, Cybersecurity, Privacy, Legal, and Commercial partners, helping digital products reach customers quickly, compliantly, and sustainably across global markets. The position develops global regulatory strategies; determines classification, qualification, and regulatory pathways; leads premarket submissions and FDA interactions; and advises cross-functional teams on regulatory risk and trade-offs. It guides software change management, AI/ML and cybersecurity strategy, and regulatory compliance throughout the product lifecycle, including labeling, promotional content, postmarket activities, audits, and regulatory intelligence. The leader also establishes scalable processes and manages team priorities, resourcing, and budget. The position is based in Sunnyvale, California, with travel up to 20% for health authority meetings, site visits, and conferences. Intuitive and/or its customers may require current proof of vaccination against certain diseases, including COVID-19, depending on the role. Compensation includes base pay, incentives, benefits, and equity; the posting notes that pay depends on job level and candidate qualifications but does not provide specific target compensation amounts in the supplied text.

Requirements

Bachelor's degree in engineering, life sciences, computer science, or a related technical field.
At least 8 years of regulatory affairs experience in medical devices, including at least 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 and 21 CFR Part 11), EU MDR, and software lifecycle and cybersecurity requirements.
At least 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.

Nice To Haves

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.

Responsibilities

Develop and execute global regulatory strategies for digital products aligned with business priorities and product roadmaps.
Determine device classification, qualification, and regulatory pathways 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 product design.
Represent Regulatory Affairs on digital product core teams and governance forums.
Assess and oversee the non-medical device product portfolio, including determining non-device status, maintaining supporting rationale and documentation, and ensuring claims, labeling, and software updates do not change regulatory status.
Lead preparation, review, and submission of 510(k), De Novo, and other premarket submissions.
Own regulatory strategy for software change management, determine when changes require new submissions, and leverage PCCPs where appropriate.
Lead FDA interactions, including pre-submission meetings and responses to deficiency requests.
Apply FDA software guidance and consensus standards 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.
Partner with Product Security to ensure premarket cybersecurity expectations are met, including SBOM, threat modeling, vulnerability management, and postmarket plans.
Partner with Privacy and Legal on medical device regulation and data protection requirements, including HIPAA and GDPR.
Review and approve design changes, labeling, instructions for use, and promotional or digital content for regulatory compliance.
Support postmarket activities, including complaint and adverse event assessment, field actions, and regulatory reporting for software issues.
Support FDA and MDSAP inspections and audits, and contribute to quality system procedures for software and digital development.
Maintain regulatory intelligence on digital health, SaMD, AI, and cybersecurity regulations; assess impacts and drive proactive readiness.
Recruit, develop, coach, and retain a high-performing team; set goals, allocate work, and foster an inclusive, collaborative culture.
Build scalable processes, templates, and tools to improve submission quality and speed.
Manage department priorities, resourcing, and budget for the digital portfolio.