Senior Regulatory Affairs Specialist
Core
Develop regulatory strategies, lead submissions, and ensure global compliance for complex medical products in regulated markets.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory strategies, submission packages, and compliance frameworks for new product development and market entry.
Domain
Medical Devices / Healthcare / Regulatory Affairs
Deliverable
client delivery
Required skills
Agency negotiation, strategic planning, global regulatory expertise, project leadership, technical documentation review, audit management
Preferred skills
Cross-functional collaboration, training delivery
Technologies
None stated
Responsibilities
Develop regulatory strategies for new product development and market entry; Advise cross-functional teams on global compliance requirements; Lead regulatory submissions and agency communications for US and Canada; Provide expert guidance in interpretation of international regulations; Coordinate with global regulatory teams for product registrations and variations; Review, approve, and update project documentation.