Intuitive Surgical Careers
Senior Regulatory Affairs Specialist
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182170
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 Functions of Position:
Serve as the primary regulatory representative on Product Engineering and Manufacturing teams with a focus on software and cybersecurity. Responsibilities include reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies.
Roles and Responsibilities:
• Support product development teams on regulatory issues, including review of documentation• Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets• Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filing justifications, Technical File creation/updates, Canadian License Applications.• Identify and convey requirements from applicable standards and guidance documents to project teams• Be the subject matter expert for the company in complying with FDA guidance documents regarding cybersecurity• Provide leadership on documentation issues and mentor teams on requirements• 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 or in a Science field
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)o 6 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)o Experience with new product development projects for complex productso Experience with software controlled and standalone software medical devices including cybersecurity.
o Ability to work in a fast paced environment and handle multiple projects simultaneouslyo Ability to create 510(k) submissions, memos-to-file, and technical documentation for complex new products and product changeso Strong understanding of design controls with experience in verification and validation methods and documentationo Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.o Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissionso Ability to digest and convey information to project teams from regulators including regulations, guidance documents and standardso Ability to review and provide critical feedback on design documentationo Ability to learn internal procedures and processes and implement on project teamso 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.