Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device
Core
Develop and implement US and Canada regulatory strategic and tactical planning for facial aesthetics devices and related products to enable commercialization.
Role type
Senior IC regulatory strategy lead (device)
Builds
Regulatory strategies and submissions for on-market and in-development products
Domain
Medical devices / Facial Aesthetics / US & Canada regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US and Canada regulatory strategy, product lifecycle management, Health Authority liaison, FDA interaction, regulatory submissions, strategic planning, cross-functional advisory
Preferred skills
US Class III device experience, manufacturing processes knowledge, change control assessments, affiliate regulatory strategy implementation, global regulatory experience
Technologies
Regulatory submission systems, FDA briefing packages
Responsibilities
Lead total product lifecycle activities including change assessments and annual reporting; Manage interface with Health Authorities (FDA) for key projects; Advise internal customers on regulatory issues; Coordinate and supervise regulatory submissions; Present regulatory information to cross-functional teams
Seniority
Senior, hands-on IC with strategic oversight