Canadian Regulatory Affairs, European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
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
S. or higher in Engineering or in a Science field
8 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science)
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)
Experience with new product development projects for complex products
Experience with software controlled and standalone software medical devices including cybersecurity.
Ability to work in a fast paced environment and handle multiple projects simultaneously
Ability to create 510(k) submissions, memos-to-file, and technical documentation for complex new products and product changes
Strong understanding of design controls with experience in verification and validation methods and documentation
Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.
Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
Ability to digest and convey information to project teams from regulators including regulations, guidance documents and standards
Ability to review and provide critical feedback on design documentation
Ability to learn internal procedures and processes and implement on project teams
Good interpersonal skills and able to work well with cross-functional teams
Good project management skills
Internal Number: 181474
About Intuitive Surgical
Surgical robotics was little more than a medical curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives.
With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology and procedural innovation across cardiac, urology, gynecologic, pediatric and general surgical disciplines.