Principal Regulatory Affairs Strategist at Intuitive — Sunnyvale, CA

Primary Function of Position

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

Regulatory Strategy

• 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

• 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.

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, 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

• 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.

Mandatory Notices