Senior Regulatory Affairs Specialist

Intuitive
Sunnyvale, CA
Category Engineering
Job Description
At Intuitive, we're dedicated to making surgery smarter, safer, and more human. Our Senior Regulatory Affairs Specialist role supports regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets.

Requirements

  • Lead global regulatory submissions for product registrations and variations.
  • Develop regulatory strategies for new product development and market entry.
  • Advise cross-functional teams on global compliance requirements.
  • Manage agency communications for complex product approvals.
  • Provide expert guidance in interpretation of international regulations.
  • Review, approve, and update regulatory labeling and documentation.
  • Mentor and coach regulatory affairs specialists.
  • Track and report metrics on regulatory timelines and success rates.
  • Represent regulatory affairs team in project meetings.

Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401k Matching
  • Tuition Reimbursement
  • Relocation Assistance
  • Generous Paid Time Off
  • Flexible Spending Account
  • Employee Assistance Program
  • Life Insurance
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