Global Regulatory Lead – Strategy & Submissions

Intuitive; California; On-site; USD 250,000 - 380,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a seasoned Regulatory leader to drive enterprise-wide product compliance and market expansion in the US and Canada. You will develop global regulatory strategies, manage submissions, and mentor teams while partnering with executives across functions to navigate evolving standards and ensure timely approvals.

This role requires a strategic mindset, strong writing and negotiation skills, and a track record obtaining FDA clearances for

Qualifications

• Mastery of global regulatory affairs, strategy, and submission expertise.
• Executive-level communication and negotiation skills.
• Strong leadership and mentorship for regulatory teams.
• Advanced technical writing, analytics, and project management.
• Track record collaborating across functions and with agencies worldwide.
• Experience with ML/CADe/x validation and global regulatory requirements
• Experience gaining FDA clearances for ML, CADe/x, and complex medical devices

Responsibilities

• Develop global regulatory strategies for complex product portfolios.
• Advise executives and teams on regulatory risks, trends, and compliance options.
• Lead complex regulatory strategy, regulatory submissions, agency communications for the US and Canada.
• Lead response to major regulatory agency inquiries, inspections, and audits.
• Develop training materials on new regulations and regulatory changes.
• Review, approve and update project documentation.
• Track and analyze global regulatory changes and their impact on the business.
• Mentor regulatory team members.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Provide metrics, dashboards, and executive communication on regulatory efforts.
• Represent company in industry and regulatory forums.

Skills

Regulatory strategy

Regulatory submissions

Executive communication

Leadership

Technical writing

Analytics

Project management

Cross-functional collaboration

FDA clearances

ML/CADe/x validation

Education

Bachelor’s degree in a relevant discipline

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a seasoned Regulatory leader to drive enterprise-wide product compliance and market expansion in the US and Canada. You will develop global regulatory strategies, manage submissions, and mentor teams while partnering with executives across functions to navigate evolving standards and ensure timely approvals.

This role requires a strategic mindset, strong writing and negotiation skills, and a track record obtaining FDA clearances for