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Intuitive Surgical

Senior Regulatory Affairs Specialist - NPD Clinical Studies

Sunnyvale, CA, United States

Job at a glance

Workplace
On-site
Sector
Legal
Posted
Nov 2, 2026
First found
Nov 2, 2026, 4:32 PM ET

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About the job

Job Description

Primary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products. Essential Job Duties • Develop regulatory strategies for new product development and market entry. • Advise cross-functional teams on global compliance requirements. • Lead regulatory submissions, agency communications and strategy for the US and Canada for complex product approvals. • Provide expert guidance in interpretation of international regulations. • Represent regulatory affairs team in project meetings. • Coordinate with OUS global regulatory teams for product registrations and variations. • Review, approve, and update project documentation.