Intuitive Surgical Careers
Regulatory Affairs Specialist, Asia Pacific and Latin America
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 180311
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Primary Function of Position:
Coordinate, prepare, or review regulatory submissions for Asia Pacific and Latin America projects. The primary focus will be Latin America countries for this position.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Create awareness within the organization regarding the international and domestic regulations and the product specific standards. Additional responsibilities include maintaining regulatory filings and licenses.
Roles and Responsibilities:
- Maintain knowledge of regulatory affairs guidelines of Korea, Japan, China, Taiwan and other Asia Pacific countries (APAC) and Latin America countries
- Compile and maintain regulatory documentation database and system
- Coordinate, prepare regulatory filings of summary technical documents and work with in-country regulatory personnel to submit it to regulatory authorities in Asia Pacific and Latin America regions
- Collect supporting documents for submissions in APAC and Latin America regions
- Create/order/legalize CFGs to support submissions
- Provide feedback and recommendations to cross-functional team regarding new product plans
- Assess changes and prepare/submit notifications to in-country regulatory personnel for new products and changes to existing products in Asia Pacific region and Latin America regions
- Support product development team and other departments with regards to implementation of regulatory requirements to assure compliance
- Help determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
- Maintain regulatory clearances and approvals with necessary filings and communications
- Create RAO/MCOs/ECOs as needed
- Continuous improvement of the submission process
- Update registration licensing and collect information on registration instructions and regulations
- Assist with recall or market withdrawal activities as necessary
- Update Regulatory SAP list
- B.S./B.E. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
- Medical device RA experience is required.
- International RA experience is required.
- Non-technical degree with equivalent complex medical device experience acceptable
- RAC (regulatory affairs certified) desirable
- Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
- Good interpersonal skills and able to work well with cross-functional teams
- Self-motivated and self-starter
- Good project management skills
- Critical thinking skills
- Ability to speak and write in Spanish is a plus.
• 4-6 years relevant experience working in a medical device company.
• 2 + years of experience in submissions and technical documentation for APAC and/or Latin America countries at a medical device company.
• Experience with new product development projects for complex products.
• Experience with both capital equipment and disposable devices
• Experience in verification and validation methods and documentation.
Training at Intuitive (on the job):
• Agile: Be able to create, review, and approve ECOs. Facile in using Agile search capability to research change history on documents, parts and assemblies.