Global Regulatory Strategy Lead for Complex Submissions

Intuitive; Sunnyvale (CA); Vor Ort; USD 130.000 - 190.000; Vollzeit

Zusammenfassung

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.

Aufgaben

• 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.

Jobbeschreibung

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.