Regulatory Affairs Technical Lead at Intuitive · Sunnyvale, CA · Joined
I
Regulatory Affairs Technical Lead
Intuitive · Sunnyvale, CA · Just now · 0 applicants
NewHybridFull-timeLead
Pay
$182k–$262kListed
Workplace
Hybrid
Job type
Full-time
Level
Lead
Team: Regulatory Affairs · Source: jobright · Posted by joined-scrapper
About the role
Intuitive is hiring a Regulatory Affairs Technical Lead to drive regulatory strategy for enterprise-wide surgical platforms, leading submissions, agency engagement, and cross-functional collaboration in a hybrid Sunnyvale role.
What you’ll do
Drive regulatory strategy and initiatives for enterprise-wide products or platforms
Support compliance and market expansion through regulatory submissions
Engage with regulatory agencies worldwide
Collaborate cross-functionally to align regulatory goals
Lead regulatory teams and provide mentorship
Manage technical writing and analytics for submissions
What you’ll need
10-12 years of experience in regulatory affairs and bachelor's degree in relevant discipline or equivalent
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
Experience with ML/CADe/x validation and FDA clearances for complex medical devices
Original job description
Intuitive develops robotic-assisted surgical technologies and minimally invasive care solutions. The Regulatory Affairs Technical Lead drives regulatory strategy and initiatives for enterprise-wide products or platforms, supporting compliance and market expansion through regulatory submissions, agency engagement, and cross-functional collaboration.10-12…