Intuitive Surgical Careers
Regulatory Affairs Associate
Primary Location: United States-California-Santa Clara County-Sunnyvale
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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
- 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