Global Regulatory Strategy Lead – OUS Markets

Intuitive; California; On-site; USD 180,000 - 230,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks an experienced Regulatory Affairs professional to lead expert support for regulatory project management, strategic submissions, and cross-functional compliance in OUS markets for complex products.

You will coordinate global regulatory teams, shape strategies, and ensure compliance across Asia Pacific and Latin America, collaborating with product, clinical, and quality teams.

Qualifications

• 8+ years of experience in regulatory affairs
• Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets
• Strong knowledge of global regulatory requirements and registration processes

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 affairs

Global regulatory submissions

Project leadership

Regulatory strategy

Documentation review

Education

Bachelor’s degree in a relevant discipline

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks an experienced Regulatory Affairs professional to lead expert support for regulatory project management, strategic submissions, and cross-functional compliance in OUS markets for complex products.

You will coordinate global regulatory teams, shape strategies, and ensure compliance across Asia Pacific and Latin America, collaborating with product, clinical, and quality teams.