Global Regulatory Lead – Strategy, Submissions & Compliance

Intuitive Surgical, Inc.; Sunnyvale (CA); Vor Ort; USD 155.000 - 262.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale seeks a senior regulatory leader to drive enterprise-wide regulatory initiatives, shape strategy, and collaborate with executives and cross-functional teams to ensure compliance and market expansion.

You will mentor regulatory professionals, oversee submissions and agency communications for the US and Canada, and lead responses to inquiries and inspections, while aligning with ML/CADe/x validation requirements.

Qualifikationen

• 10-12 years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience.

Aufgaben

• 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.

Kenntnisse

Regulatory strategy

Executive communication

Leadership & mentorship

Technical writing

Cross-functional collaboration

ML/CADe/x validation

FDA clearances

Ausbildung

Bachelor's degree in a relevant discipline

Jobbeschreibung

Intuitive Surgical, Inc. in Sunnyvale seeks a senior regulatory leader to drive enterprise-wide regulatory initiatives, shape strategy, and collaborate with executives and cross-functional teams to ensure compliance and market expansion.

You will mentor regulatory professionals, oversee submissions and agency communications for the US and Canada, and lead responses to inquiries and inspections, while aligning with ML/CADe/x validation requirements.