Principal Regulatory Affairs

Job description

Primary Function of Position This is a principal-level individual contributor role responsible for regulatory strategy across a complex surgical platform. This role will work across robotic and surgical systems, instruments, accessories, disposables, and the imaging, sensing, and connected capabilities that support them, shaping submission and lifecycle strategy from early design through post-market. Working independently and with broad discretion in setting regulatory objectives, approaches, and recommendations for critical assignments, this role helps senior leaders connect product design, intended use, clinical workflow, risk management, and quality requirements to a robust regulatory approach in the U.S. and international markets. The role influences product and portfolio decisions, represents the company in interactions with regulators and standards bodies, and provides technical direction and mentoring to cross functional teams. Essential Job Duties Regulatory Strategy & Advisory Leadership • Lead regulatory strategy across the surgical platform, including robotic and surgical systems, instruments, accessories, disposables, and their associated software and digital capabilities. • Advise senior leaders on regulatory options for new products, significant design changes, and portfolio decisions. • Lay out the regulatory risks, trade-offs, and recommended path for each option. • Assess the regulatory health of assigned programs by identifying risks, gaps, dependencies, and decision points, and recommend actions that guide cross-functional priorities. • Connect intended use, human factors, interoperability, and clinical workflow to classification, submission pathway, and clinical evidence strategy. Submissions & Lifecycle Management • Develop the submission strategy for premarket authorizations across pathways (510(k), De Novo, PMA, HDE) and their international equivalents. • Guide preparation of premarket submissions and lead substantive interactions with regulatory agencies. • Lead regulatory strategy for clinical investigations, including IDEs and related study submissions. • Advise on international clinical investigation requirements that support evidence generation and market access. • Guide post-market regulatory activities such as recalls, field actions, adverse event reporting, and inspection and audit responses Standards, Quality & Cross-Functional Partnership • Partner with R&D, quality, clinical, and manufacturing teams to build regulatory considerations into design, risk management, and the quality system from the outset. • Apply and help shape relevant consensus standards (ISO, IEC, AAMI, and other FDA-recognized standards) in design and submission strategy. • Mentor regulatory and cross-functional colleagues and provide technical guidance, without direct management responsibility. Agency Engagement & External Representation • Represent the company with regulatory agencies, notified bodies, standards organizations, and industry groups. • Support regulatory strategies for international market access. • Track regulatory developments and emerging expectations, including those affecting surgical system, software, connected, and data-enabled features, and translate them into practical guidance for the business Required Experience and Education • Minimum 15 years of related regulatory affairs experience with a bachelor's degree; or 12 years with a master's degree; or a PhD with 8 years of experience; or an equivalent combination of education and experience. • Bachelor's degree in engineering, life sciences, or a related technical discipline required; PhD preferred. • Regulatory Affairs Certification (RAC) preferred. • Experience with international standards development, standards interpretation, or the use of consensus standards in regulatory submissions preferred. Required Knowledge, Skills and Abilities • Deep expertise in regulatory strategy for complex medical device systems, including surgical platforms, instruments, accessories, disposables, and associated software or digital features. • Knowledge of the regulatory considerations for software, digital health, cybersecurity, data-enabled features, and AI/ML- enabled functionality. • Strong command of FDA and international medical device regulatory requirements, submission pathways, and quality system regulations (e.g., 21 CFR 820, ISO 13485). • Working knowledge of the consensus standards relevant to surgical and complex medical devices (ISO, IEC, AAMI) and how to apply them in design and submissions. • Track record of representing a company with regulatory agencies, standards bodies, or industry groups. • Track record of working with and influencing across functions (R&D, clinical, quality, product, and business leadership). 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. 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. 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.