Senior Regulatory Strategy Architect - Medical Devices

Intuitive; Sunnyvale (CA); On-site; USD 212,000 - 318,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Principal Regulatory Affairs Strategist to shape early regulatory and clinical strategies for emerging surgical technologies.

This individual contributor role collaborates with R&D, Clinical Affairs, Quality, and Product to set intended use, indications, and validation paths for market authorization, with a focus on US and international compliance and strategy.

Qualifications

• Bachelor’s degree in engineering, life sciences, clinical science, or related technical field required; advanced degree preferred.
• Experience defining and executing clinical evidence programs, including early feasibility and pivotal investigations.
• Experience with software, digital health, cybersecurity, data-enabled features, and AI/ML-enabled functionality regulatory considerations.
• Track record of engaging with FDA, notified bodies, or international health authorities on difficult regulatory questions.

Responsibilities

• Develop and lead early regulatory strategy for the surgical platform and product families (robotic systems, instruments, disposables, software).
• Shape product direction early in the lifecycle and advise on regulatory consequences of intended use, indications, claims, and design choices.
• Develop regulatory strategies for US and international markets and translate into executable plans.
• Advise senior leaders on regulatory risks and trade-offs for programs with ambiguous pathways.
• Define the clinical evidence strategy to support regulatory authorization, including study design logic and endpoints.
• Lead or contribute to early clinical investigations (US IDEs, EU investigations) and other international study requirements.
• Collaborate with Clinical Affairs to plan investigations that support regulatory strategy and market access goals.
• Assess feasibility vs pivotal evidence needs and defend decisions with regulators and stakeholders.

Education

Bachelor's in engineering or life sciences

Advanced degree preferred

Regulatory strategy

Clinical evidence strategy

FDA/health authority engagement

Cross-functional leadership

Software/digital health/AI/ML regulatory

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Principal Regulatory Affairs Strategist to shape early regulatory and clinical strategies for emerging surgical technologies.

This individual contributor role collaborates with R&D, Clinical Affairs, Quality, and Product to set intended use, indications, and validation paths for market authorization, with a focus on US and international compliance and strategy.