Senior Global Regulatory Affairs Lead – OUS

Intuitive; Sunnyvale (CA); On-site; USD 152,000 - 218,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Regulatory Affairs Specialist to provide expert support for OUS regulatory projects and cross-functional compliance for complex products. You will coordinate global teams, shape regulatory strategies, and ensure timely submissions across markets.

The role calls for guiding cross-functional partners, interpreting international regulations, and representing the regulatory affairs function in project meetings.

Qualifications

• 8+ years of experience in regulatory affairs.
• Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets.

Responsibilities

• Coordinate and manage OUS global regulatory teams for product registrations and variations.
• Assist with regulatory strategies for OUS markets.
• Advise cross-functional teams on global compliance requirements.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Review, approve, and update project documentation.

Skills

Regulatory leadership

Global submissions

Project management

Regulatory strategy

Cross-functional

Regulatory interpretation

Education

Bachelor's degree

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Regulatory Affairs Specialist to provide expert support for OUS regulatory projects and cross-functional compliance for complex products. You will coordinate global teams, shape regulatory strategies, and ensure timely submissions across markets.

The role calls for guiding cross-functional partners, interpreting international regulations, and representing the regulatory affairs function in project meetings.