Senior Regulatory Affairs Specialist
Intuitive•Sunnyvale, CA
•$128,900 - $218,300•Onsite
About The Position
This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in outside-the-U.S. (OUS) regulated markets for complex products. It coordinates and manages global regulatory teams for product registrations and variations, supports regulatory strategies for OUS markets, advises cross-functional teams on global compliance requirements, and provides expert interpretation of international regulations. The role also 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 the interpretation of 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Senior
