Primary Function of Position: 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 Develop regulatory pathway for US FDA and Canada new product registration, support product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements. Assess the impact of the product and process changes, determine regulatory pathways for US and Canada markets, and prepare 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 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. Working Conditions None Preferred Skills and Experience RAPS - RAC Certification is a plus
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who