Senior Global Regulatory Strategy Lead

Intuitive; California; On-site; USD 180,000 - 240,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, is seeking an experienced Regulatory Affairs professional in California. The role involves expert support for regulatory project management, strategic submissions, and cross-functional compliance activities across global regulated markets for complex medical devices.

You will develop regulatory strategies for new product development, advise cross-functional teams on global requirements, and lead submissions and agency communications for US

Qualifications

• 8+ years of experience in regulatory affairs and a bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.
• Experience with audits, submissions, and training.
• Expertise in global regulatory requirements and registration processes.

Responsibilities

• 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.

Skills

Regulatory strategy

Global regulations

Project leadership

Technical docs review

Audits & submissions

Education

Bachelor’s degree

Job description

Intuitive, a global leader in robotic-assisted surgery, is seeking an experienced Regulatory Affairs professional in California. The role involves expert support for regulatory project management, strategic submissions, and cross-functional compliance activities across global regulated markets for complex medical devices.

You will develop regulatory strategies for new product development, advise cross-functional teams on global requirements, and lead submissions and agency communications for US