Principal Regulatory Affairs Strategist

Principal Regulatory Affairs Strategist

This is a principal-level individual contributor role responsible for early regulatory and clinical strategy for emerging surgical technologies. The Principal Regulatory Affairs Strategist works upstream with R&D, Clinical Affairs, Quality, Product, and business stakeholders to shape intended use, indications, claims, classification, evidence needs, regulatory pathway, and global market access strategy before submission plans are fully defined.

The role is focused on strategy, judgment, and senior-level advisory impact rather than day-to-day submission execution or post-market lifecycle ownership. The strategist develops practical US and OUS regulatory options for programs, guides clinical evidence strategy, and helps senior leaders understand the risks, trade-offs, and decisions needed to move technologies toward market authorization.

Essential Job Duties include:

• Develop and lead early regulatory strategy for the surgical platform and its product families robotic and surgical systems, instruments, accessories, disposables, and their associated software and digital capabilities.
• Shape product direction early in the product life cycle and advise on the regulatory consequences of intended use, indication, claims, classification, and design choices.
• Develop regulatory strategies for both US and OUS markets.
• Translate regulatory strategies into detailed, executable plans.
• Advise senior leaders and cross-functional teams on regulatory risks, trade-offs, and decision points for programs with ambiguous pathways or significant clinical evidence needs.

Clinical Strategy includes:

• Define the clinical evidence strategy needed to support regulatory authorization for novel or complex medical technologies, including evidence plans, study design logic, endpoint selection, comparator considerations, and related clinical adoption and market access considerations.
• Lead or contribute to strategy for early clinical investigations, including US IDEs, EU clinical investigations, and other international study requirements that support product development, evidence generation, and market access.
• Partner with Clinical Affairs and Clinical Operations to ensure early clinical investigations are planned and executed in a way that supports regulatory strategy, evidence needs, and market access goals.
• Assess when feasibility evidence, pivotal evidence, or post-market data best serves a program, and defend that judgment with regulators, internal reviewers, and clinical stakeholders.

Qualifications

Required Experience and Education include:

• 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, clinical science, or a related technical discipline required; advanced degree preferred, particularly in a relevant scientific, engineering, or clinical field.
• Experience working with Clinical Affairs, Clinical Operations, investigators, or clinical experts to support planning and execution of early clinical investigations.
• Experience defining and executing clinical evidence programs, including early feasibility and pivotal investigations conducted under ISO 14155 and applicable good clinical practice expectations.
• Experience with regulatory considerations for software, digital health, cybersecurity, data-enabled features, and AI/ML-enabled functionality.
• Experience supporting diligence, partnership, acquisition readiness, or investment decision-making through regulatory, clinical, and quality strategy.

Required Knowledge, Skills and Abilities include:

• Track record of developing regulatory strategies for novel, first-of-kind, or high-risk medical technologies.
• Track record of leading successful market authorizations in US and OUS markets.
• Track record of defining clinical evidence strategy, including study design logic, endpoint selection, comparator strategy, and evidence requirements for regulatory authorization, clinical adoption, and market access.
• Track record of direct, substantive engagement with FDA, notified bodies, or international health authorities on difficult regulatory questions.
• Track record of working with and influencing across functions R&D, clinical, quality, product, and business leadership.

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 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.