Senior Regulatory Affairs Specialist - OUS Support
Intuitive•Sunnyvale, CA
About The Position
This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in OUS regulated markets for complex products. The specialist coordinates global regulatory teams for product registrations and variations, supports regulatory strategies for OUS markets, advises cross-functional teams on global compliance requirements, interprets international regulations, represents Regulatory Affairs in project meetings, and reviews, approves, and updates project documentation.
Requirements
- At least 8 years of experience in regulatory affairs and a bachelor’s degree in a relevant discipline, or an equivalent combination of education and experience.
- Experience with complex product submissions for Asia Pacific, Latin America, and other OUS markets.
- Proficiency in OUS agency negotiation and strategic planning.
- Expertise in global regulatory requirements and registration processes.
- Advanced project leadership and communication skills.
- Ability to review and approve technical documentation.
Responsibilities
- 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 interpreting international regulations.
- Represent the Regulatory Affairs team in project meetings.
- Review, approve, and update project documentation.
Benefits
- Market-competitive compensation packages, including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
