Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist at Intuitive serves as the primary regulatory representative on product and project teams, supporting product lifecycle management activities. This role involves developing regulatory plans, reviewing design input/output documentation, identifying 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.
Key responsibilities include leading global regulatory submissions for product registrations and variations, developing regulatory strategies for new product development and market entry, advising cross-functional teams on global compliance requirements, overseeing the preparation of technical files and documentation for audits, managing agency communications for complex product approvals, providing expert guidance in the interpretation of international regulations, reviewing, approving, and updating regulatory labeling and documentation, mentoring and coaching regulatory affairs specialists, tracking and reporting metrics on regulatory timelines and success rates, and representing the regulatory affairs team in project meetings.
Candidates should have a minimum of 6–8 years of experience in regulatory affairs, with a bachelor's degree in a relevant discipline or an equivalent combination of education and experience. Expertise in global regulatory requirements and registration processes is essential, along with advanced project leadership and communication skills, technical documentation review and approval capabilities, agency negotiation and strategic planning proficiency, experience with audits, submissions, and training, experience with ML/CADe/x validation and global regulatory requirements, experience gaining FDA clearances for ML, CADe/x, and complex medical devices, and experience mentoring regulatory team members.
The compensation for this role varies by region, with a minimum salary of $128,900 USD and a maximum of $185,600 USD in Region 2, and a minimum of $151,700 USD and a maximum of $218,300 USD in Region 1. The position is full-time with a day shift and requires onsite work weekly, with the percentage of onsite work defined by the leader.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci surgical system and Ion transforming how care is delivered for millions of patients worldwide. The company fosters a team of engineers, clinicians, and innovators united by the purpose of making surgery smarter, safer, and more human. Employees are encouraged to contribute to something bigger than themselves and help transform the future of healthcare.