Senior Global Regulatory Affairs Lead — Submissions

Regulatory Jobs; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Regulatory Affairs leader to provide expert support for regulatory project management, strategic submissions, and cross-functional compliance in global markets.

The role focuses on leading submissions, developing regulatory strategies, and guiding cross-functional teams to ensure timely approvals and compliant labeling across international markets.

Qualifications

• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.
• Agency negotiation and strategic planning proficiency.

Responsibilities

• Lead global regulatory submissions for product registrations and variations.
• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Oversee preparation of technical files and documentation for audits.
• Manage agency communications for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Review, approve, and update regulatory labeling and documentation.
• Mentor and coach regulatory affairs specialists.
• Track and report metrics on regulatory timelines and success rates.
• Represent regulatory affairs team in project meetings.

Skills

Regulatory requirements

Project leadership

Documentation review

Agency negotiations

Audits & submissions

Education

Bachelor's degree in a relevant discipline

Job description

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Regulatory Affairs leader to provide expert support for regulatory project management, strategic submissions, and cross-functional compliance in global markets.

The role focuses on leading submissions, developing regulatory strategies, and guiding cross-functional teams to ensure timely approvals and compliant labeling across international markets.