Senior Regulatory Affairs Specialist

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Intuitive in Sunnyvale, CA seeks a Regulatory Affairs professional to provide expert support for global regulatory project management, strategic submissions, and cross-functional compliance activities for complex products.

You will lead submissions to the US FDA and Health Canada, advise teams on international requirements, coordinate with regional regulatory groups, and ensure documentation is audit-ready and current.

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.

Job description

Job Description

Primary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products.

Essential Job Duties

• 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.