Senior Regulatory Affairs Specialist - OUS Support
Core
Expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in OUS regulated markets for complex products.
Role type
Senior Regulatory Affairs Specialist (Global Markets)
Builds
Product registrations and variations for OUS markets
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
OUS Agency negotiation, strategic planning, global regulatory requirements expertise, registration processes, project leadership, technical documentation review
Preferred skills
Advanced communication skills
Technologies
None stated
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 interpretation of international regulations; Represent regulatory affairs team in project meetings; Review, approve, and update project documentation