Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201040
Provide leadership to development, new product introduction, and manufacturing teams for assessing the impact of design inputs and outputs on regulatory filings and compliance. Create awareness within the organization regarding international and domestic regulations and product specific standards. Additional responsibilities include maintaining regulatory filings and licenses, and interacting with regulatory agencies during inspections.
- Prepare and submit 510(k)s (FDA) to obtain regulatory clearances for new products, new indications, and significant product changes in a timely manner.
- Prepare “Memo to File” documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals.
- Prepare and maintain Technical Files for Europe (CE Mark) for new products, new indications, and significant product changes in a timely manner..
- Support product development teams on regulatory issues, including review of documentation.
- Provide leadership on documentation issues and mentor teams on regulatory requirements
- Support continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
- Work directly with regulatory agencies on regulatory issues and submissions.
- Support international regulatory efforts as needed.
- Perform other duties as required.
- B.S. or higher in Engineering [Sr. Regulatory Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist]
- Minimum 5 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science) and/or applicable work for a regulatory agency
- 4 years of experience in submissions and technical documentation for medical devices (can be in combination with a regulatory degree e.g., Masters in Regulatory Science plus 3 years) and/or applicable work for a regulatory agency (2 years minimum)
- Experience with new product development projects for complex products
- Ability to create 510(k) submissions, memo-to-files, and technical documentation for complex new products
- Understanding of design controls with experience in verification and validation methods and documentation
- Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
- 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
- Good project management skills