Intuitive Surgical Careers

Regulatory Affairs Associate

Sunnyvale, California
Clinical / Regulatory

Job Description

Job: Clinical / Regulatory
Primary Location: United States-California-Santa Clara County-Sunnyvale
Schedule: Full-time


Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function

The Regulatory Affairs Associate will assist with Asia Pacific and Latin America projects and duties including System and I&A registrations, facility registrations, and other duties as needed. The Regulatory Affairs Associate will support regulatory submissions and compliancer in Asia Pacific and Latin America regions.

Roles and Responsibilities
  • Coordinate document preparation to support various registrations, certifications and license applications in Asia Pacific and Latin America countries 
    • Review product labeling, records, design documents, etc. for submissions and compliance with applicable regulations and policies. Collect all necessary supporting documents for submissions.
    • Communicate with distributors regarding submission activities
    • Prepare additional information or responses as requested by regulatory agencies
    • Prepare and submit notifications to in-country regulatory personnel for new products and changes to existing products in Asia Pacific and Latin America regions. Keep all necessary records for change notifications.
  • Coordinate with distributors and subsidiaries regarding surveys
  • Maintain electronic libraries of applicable standards, test reports, certificates, licenses, declaration of conformities, and other documentation to support regulatory submissions.
  • Maintain department database of all applicable international contacts, agencies and consultants required for international registrations. 
  • Maintain registration databases and project status for APAC and Latin America registrations.
  • Maintain a product list for Certificate for Foregin Government (CFG) and create, order, and legalize CFGs to support submissions for other team members
  • Perform support activities included but not limited to
    • Maintain a list of Purchase Requests and Purchase Orders
    • Update Regulatory SAP list 
    • CreateRAO/MCOs/ECOs as needed
    • Assist with research and analysis of regulations
  • Perform other duties as required

Skill/Job Requirements:
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint)
  • Agile experience preferred
  • Bachelor’s degree
  • Limited regulatory submission preparation experience a plus 
  • Good oral and written communication and interpersonal skills
  • Strong attention to detail
  • Self-motivated and willingness to help others
  • Ability to work in a fast-paced and dynamic environment
  • Ability to handle multiple projects and deadlines simultaneously in a team setting
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.