Primary Function of PositionThis role leads regulatory initiatives for enterprise-wide products or platforms, drives regulatory strategy, and collaborates with executive and cross-functional teams for compliance and market expansion.
Essential Job Duties- Develop global regulatory strategies for complex product portfolios.
- Advise executives and teams on regulatory risks, trends, and compliance options.
- Lead complex regulatory strategy, regulatory submissions, agency communications for the US and Canada.
- Lead response to major regulatory agency inquiries, inspections, and audits.
- Develop training materials on new regulations and regulatory changes.
- Review, approve and update project documentation.
- Track and analyze global regulatory changes and their impact on the business.
- Mentor regulatory team members.
- Coordinate with OUS global regulatory teams for product registrations and variations.
- Provide metrics, dashboards, and executive communication on regulatory efforts.
- Represent company in industry and regulatory forums.
QualificationsRequired Education and Training- 10-12 years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience.
Required Skills and Experience- Mastery of global regulatory affairs, strategy, and submission expertise.
- Executive-level communication and negotiation skills.
- Strong leadership and mentorship for regulatory teams.
- Advanced technical writing, analytics, and project management.
- Track record collaborating across functions and with agencies worldwide.
- Experience with ML/CADe/x validation and global regulatory requirements
- Experience gaining FDA clearances for ML, CADe/x, and complex medical devices
Working ConditionsAdditional InformationDue 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.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
