Intuitive Surgical Careers
Senior Regulatory Affairs Specialist - China
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 190540
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:
Work with IntuFosun (China local agent) to coordinate, prepare, or review regulatory submissions for China projects.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Create awareness within the organization regarding Chinese regulations and the product specific standards. Additional responsibilities include maintaining regulatory filings and licenses.
Roles & Responsibilities:
Qualifications• Maintain knowledge of regulatory affairs guidelines of China• Provide project management for the deliverables to local RA in support of the technical files or the technical file supplements• Participate in team meetings with local RAs, ensure clarity and alignment on what is needed and take ownership of any gaps/deliverables identified• 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• Collect supporting documents for submissions in China• Work with cross-functional teams to communicate/ incorporate regional regulatory requirements into project deliverables, including procedures and processes• Work with cross-functional teams to create/review required documents for submissions/importations for China• Support clinical studies if any• Facilitate translation of any official communication from the government and file it with the technical files• Coordinate translation of the submissions in English/Chinese• Document and archive bilingual submission files in Agile• Support type testing• 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 China• Track changes for China to secure inventory and track amendment submissions• 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• Help maintain regulatory clearances and approvals with necessary filings and communications• Create change orders (RAO/MCOs/ECOs) on Agile as needed• Continuous improvement of the submission process - identify department gaps and initiate and implement processes/procedures to improve those gaps• Assist with recall or market withdrawal activities as necessary• Perform other duties as required
Skills, Experience, Education, & Training:
Education & Skills:
• 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.• Chinese language capability is desired.• Non-technical degree with equivalent complex medical device experience acceptable• 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• Ability to work in a fast-paced and dynamic environment• Good project management skills – Ability to work on multiple projects concurrently to meet deadlines with minimal supervision• Critical thinking skills• Proficient in PC applications
• 5-8 years relevant experience working in a medical device company or other regulated fields (e.g. Pharmaceutical).• 3 + 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• Experience in verification and validation methods and documentation.
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.