Intuitive Surgical Careers
Regulatory Affairs Specialist - APAC & Latin America
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 181535
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 of Position:
Coordinate, prepare, or review regulatory submissions for Asia Pacific and Latin America projects. 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 countriesQualifications
• 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
• Perform other duties as required
• B.S./B.E. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
• RA experience in Medical Device or other regulated fields (e.g. Pharmaceutical) is required.
• International RA experience is desired.
• 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
• 4-6 years relevant experience working in a medical device company or other regulated fields (e.g. Pharmaceutical).• 2 + years of experience in submissions and technical documentation.• Experience with new product development projects for complex products.• Experience with both capital equipment and disposable devices preferred.• 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.
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.