Senior Regulatory Affairs Specialist
Intuitive Surgical, Inc. in
Job Description
Primary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products.
Essential Job Duties
- 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.
Vacancy posted 8 hours ago
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