Regulatory Affairs Technical Lead

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Intuitive in Sunnyvale, CA seeks a regulatory leader to drive enterprise-wide compliance and market expansion. You will shape global regulatory strategy and collaborate with executives to navigate complex regulatory landscapes.

The role includes leading US/Canada submissions, managing agency communications, mentoring the team, and delivering metrics and executive updates to inform strategic decisions.

Responsibilities

• Develop global regulatory strategies for complex product portfolios.
• Advise executives on regulatory risks, trends, and compliance options.
• Lead regulatory strategy, submissions, agency communications for US/Canada.
• Lead responses to inquiries, inspections, and audits by regulatory agencies.
• Develop training materials on new regulations and regulatory changes.
• Review, approve and update project documentation.
• Track and analyze global regulatory changes and impact on the business.
• Mentor regulatory team members.
• Coordinate with international regulatory teams for registrations and variations.
• Provide metrics and executive dashboards on regulatory efforts.
• Represent the company in industry and regulatory forums.

Skills

Regulatory strategy

Regulatory submissions

Agency communications

Regulatory risk analysis

Training material development

Documentation review

Regulatory monitoring

Mentoring

Cross-functional collaboration

Executive reporting

Job description

Job Description

Primary Function of Position

This role leads regulatory initiatives for enterprise-wide products or platforms, drives regulatory strategy, and collaborates with executive and cross-functional teams for compliance and market expansion.

Essential Job Duties

• Develop global regulatory strategies for complex product portfolios.
• Advise executives and teams on regulatory risks, trends, and compliance options.
• Lead complex regulatory strategy, regulatory submissions, agency communications for the US and Canada.
• Lead response to major regulatory agency inquiries, inspections, and audits.
• Develop training materials on new regulations and regulatory changes.
• Review, approve and update project documentation.
• Track and analyze global regulatory changes and their impact on the business.
• Mentor regulatory team members.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Provide metrics, dashboards, and executive communication on regulatory efforts.
• Represent company in industry and regulatory forums.