Senior Regulatory Affairs Specialist - NPD Clinical Studies
Core
Develop regulatory strategies for new product development and market entry for complex medical products in global regulated markets.
Role type
Senior Regulatory Affairs Specialist (NPD Clinical Studies)
Builds
Regulatory submissions and market entry strategies for complex medical products
Domain
Medical Devices / Regulatory Affairs
Required skills
Agency negotiation, strategic planning, global regulatory requirements expertise, registration processes, project leadership, technical documentation review
Preferred skills
Audits, submissions, training
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
Seniority
Senior, 6-8 years experience