Senior Regulatory Affairs Lead - NPD & Clinical Studies

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

Job summary

Intuitive Surgical, Inc. is seeking a regulatory affairs professional to provide expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products.

You will develop regulatory strategies for product development, lead submissions for US and Canada, advise cross‑functional teams on international requirements, and coordinate with global teams to ensure timely registrations while maintaining compliance.

Qualifications

• Bachelor's degree in a relevant discipline and 6-8 years of regulatory affairs experience.
• Experience with global regulatory requirements and registrations.
• Strong project leadership and communication skills.

Responsibilities

• Develop regulatory strategies for new product development and market entry.
• Lead global regulatory submissions and agency communications.
• Advise cross-functional teams on global compliance requirements.
• Coordinate with OUS teams for registrations and variations.
• Review, approve, and update project documentation.

Skills

Agency negotiation

Global regulations

Project leadership

Documentation review

Audits & submissions

Education

Bachelor's degree in a relevant discipline

Job description

Intuitive Surgical, Inc. is seeking a regulatory affairs professional to provide expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products.

You will develop regulatory strategies for product development, lead submissions for US and Canada, advise cross‑functional teams on international requirements, and coordinate with global teams to ensure timely registrations while maintaining compliance.