Regulatory Affairs Specialist 3 - Multiport da Vinci

Regulatory Affairs Specialist 3 - Multiport da Vinci

Serve as the primary regulatory representative on project and product core teams. The Regulatory Affairs Specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products.

Essential job duties include developing regulatory pathways for US FDA and Canada new product registration, supporting product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements. The role also involves assessing the impact of product and process changes, determining regulatory pathways for US and Canada markets, and preparing the corresponding regulatory submission or internal documentation.

Author regulatory submissions for US FDA 510(k) premarket notifications, internal "Letters to File" and Health Canada registration, and lead the review process through clearance/approval, where applicable. Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approvals. Create and maintain product summary technical file (STED). Identify and convey requirements from applicable standards and guidance documents to project teams. 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 activities upon request. Perform other duties as required.

Required skills and experience include the ability to work in a fast-paced environment and handle multiple projects simultaneously. Ability to author and manage US FDA and Canada submissions and review processes. Understanding of design controls with experience in verification and validation methods and documentation and their relevancy to regulatory assessments. 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 ability to work well with cross-functional teams. Good project management skills.

Required education and training typically requires a minimum of 5 years of related experience with a University degree; or 3 years experience and a Master's degree; or a PhD without experience; or equivalent work experience.