Senior Regulatory Affairs Specialist

Intuitive • Sunnyvale, CA

2d

About The Position

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets. Essential Job Duties Lead global regulatory submissions for product registrations and variations. Develop regulatory strategies for new product development and market entry. Advise cross-functional teams on global compliance requirements. Oversee preparation of technical files and documentation for audits. Manage agency communications for complex product approvals. Provide expert guidance in interpretation of international regulations. Review, approve, and update regulatory labeling and documentation. Mentor and coach regulatory affairs specialists. Track and report metrics on regulatory timelines and success rates. Represent regulatory affairs team in project meetings.

Requirements

• Minimum 8 years 6–8 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.
• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.
• Agency negotiation and strategic planning proficiency.
• Experience with audits, submissions, and training.
• Experience with ML/CADe/x validation and global regulatory requirements
• Experience gaining FDA clearances for ML, CADe/x, and complex medical devices

Nice To Haves

• Experience mentoring Regulatory team members preferred

Responsibilities

• Lead global regulatory submissions for product registrations and variations.
• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Oversee preparation of technical files and documentation for audits.
• Manage agency communications for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Review, approve, and update regulatory labeling and documentation.
• Mentor and coach regulatory affairs specialists.
• Track and report metrics on regulatory timelines and success rates.
• Represent regulatory affairs team in project meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees