Senior Regulatory Affairs Specialist

Intuitive•Sunnyvale, CA

About The Position

The Senior Regulatory Affairs Specialist provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products. The role develops regulatory strategies for new product development and market entry, advises cross-functional teams on global compliance requirements, and leads U.S. and Canadian regulatory submissions, agency communications, and approval strategies. It also provides guidance on interpreting international regulations, represents Regulatory Affairs in project meetings, coordinates with outside-the-U.S. global regulatory teams on product registrations and variations, 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.
Proficiency in 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.
Experience with audits, submissions, and training.

Responsibilities

Develop regulatory strategies for new product development and market entry.
Advise cross-functional teams on global compliance requirements.
Lead regulatory submissions, agency communications, and strategy for complex product approvals in the United States and Canada.
Provide expert guidance on interpreting international regulations.
Represent the Regulatory Affairs team in project meetings.
Coordinate with outside-the-U.S. global regulatory teams on product registrations and variations.
Review, approve, and update project documentation.