Global Regulatory Strategist - OUS Submissions

Intuitive Surgical, Inc.; Sunnyvale (CA); Vor Ort; USD 152.000 - 218.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale, CA, seeks an experienced Regulatory Affairs professional to lead regulatory project management, strategic submissions, and global compliance across non-US markets for complex medical devices.

In this role you will coordinate global regulatory teams, advise on regulatory strategies, and review critical documentation, leveraging 8+ years of experience and a relevant bachelor’s degree.

Qualifikationen

• 8+ years of experience in regulatory affairs or equivalent.
• Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets.
• Regulatory strategy and cross-functional guidance experience.

Aufgaben

• Coordinate and manage OUS global regulatory teams for product registrations and variations.
• Assist with regulatory strategies for OUS markets.
• Advise cross-functional teams on global compliance requirements.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Review, approve, and update project documentation.

Kenntnisse

Regulatory affairs

Global regulatory requirements

Project leadership

Communication skills

Ausbildung

Bachelor's degree in a relevant discipline

Jobbeschreibung

Intuitive Surgical, Inc. in Sunnyvale, CA, seeks an experienced Regulatory Affairs professional to lead regulatory project management, strategic submissions, and global compliance across non-US markets for complex medical devices.

In this role you will coordinate global regulatory teams, advise on regulatory strategies, and review critical documentation, leveraging 8+ years of experience and a relevant bachelor’s degree.