Senior Regulatory Affairs Specialist - NPD Clinical Studies

Intuitive•Sunnyvale, CA

About The Position

This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for complex products. The specialist develops regulatory strategies for new product development and market entry; advises cross-functional teams on global compliance requirements; and leads regulatory submissions, agency communications, and strategy for complex product approvals in the United States and Canada. The role also provides guidance on international regulations, represents Regulatory Affairs in project meetings, coordinates with outside-U.S. global regulatory teams on product registrations and variations, and reviews, approves, and updates project documentation.

Requirements

6–8 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 in interpreting international regulations.
Represent the Regulatory Affairs team in project meetings.
Coordinate with outside-U.S. global regulatory teams on product registrations and variations.
Review, approve, and update project documentation.