Senior Regulatory Strategy Lead, MedTech & AI

Intuitive; California (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

Intuitive Surgical seeks a Principal Regulatory Affairs Strategist to lead early regulatory and clinical strategy for emerging surgical technologies.

You will work 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.

Qualifications

• Minimum 15 years of regulatory affairs experience with a bachelor's degree; or 12 years with a master's; or a PhD with 8 years of experience.
• Bachelor’s degree in engineering, life sciences, clinical science, or a related technical discipline.
• Experience defining and executing clinical evidence programs, incl. early feasibility and pivotal investigations.
• Experience with regulatory considerations for software, digital health, cybersecurity, data-enabled features, and AI/ML-enabled functionality.

Responsibilities

• 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.

Skills

Regulatory strategy

Clinical strategy

Cross-functional collaboration

Senior-level advisory

Education

Bachelor's degree in engineering, life sciences, clinical science

Master's degree preferred

PhD with 8 years experience

Job description

Intuitive Surgical seeks a Principal Regulatory Affairs Strategist to lead early regulatory and clinical strategy for emerging surgical technologies.

You will work 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.