Intuitive Surgical Careers
Senior Regulatory Affairs Specialist
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 190331
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.
New Product/Indication Submissions:
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.
Roles and Responsibilities:
Qualifications• 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.
o B.S. or higher in Engineering [Sr. Regulatory Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist]
o 8 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 agencyo 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)o Experience with new product development projects for complex products• Skills:o Ability to create 510(k) submissions, memo-to-files, and technical documentation for complex new productso Understanding of design controls with experience in verification and validation methods and documentationo Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilizationo Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissionso Good interpersonal skills and able to work well with cross-functional teamso Good project management skills
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.