Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets. Essential Job Duties: Lead global regulatory submissions for product registrations and variations. Develop regulatory strategies for new product development and market entry. Advise cross-functional teams on global compliance requirements. Oversee preparation of technical files and documentation for audits. Manage agency communications for complex product approvals. Provide expert guidance in interpretation of international regulations. Review, approve, and update regulatory labeling and documentation. Mentor and coach regulatory affairs specialists. Track and report metrics on regulatory timelines and success rates. Represent regulatory affairs team in project meetings. Required Experience and Education: Minimum 8 years 68 years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience. Required Knowledge, Skills and Abilities: Expertise in global regulatory requirements and registration processes. 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 Experience mentoring Regulatory team members preferred Physical Requirements: Not applicable 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.

Created: 2026-03-06