Job DescriptionPrimary Function of PositionThis role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in OUS regulated markets for complex products.
Essential Job Duties- Coordinate and manage OUS global regulatory teams for product registrations and variations.
- Assist with regulatory strategies for OUS markets.
- Advise cross-functional teams on global compliance requirements.
- Provide expert guidance in interpretation of international regulations.
- Represent regulatory affairs team in project meetings.
- Review, approve, and update project documentation.
QualificationsRequired Experience and Education- 8+ years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience.
- Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets
Required Knowledge, Skills and Abilities- OUS Agency negotiation and strategic planning proficiency.
- Expertise in global regulatory requirements and registration processes.
- Advanced project leadership and communication skills.
- Technical documentation review and approval capabilities.
Physical RequirementsAdditional 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.
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.
