Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
Core
Develop and implement US and Canada regulatory strategic and tactical planning for aesthetics devices to enable product commercialization.
Role type
Senior Manager, Regulatory Strategy Lead
Builds
Regulatory strategies and submissions for aesthetics devices
Domain
Medical devices / Aesthetics / US & Canada regulatory
Required skills
Regulatory strategy planning, Health Authority interface (FDA), product lifecycle management, regulatory submissions, cross-functional advisory, complex matrix environment navigation
Preferred skills
Global regulatory experience, pharmaceutical regulatory activities, advanced degree (PharmD, PhD, MS), regulatory certification
Technologies
None stated
Responsibilities
Lead total product lifecycle activities including change assessments and annual reporting; Manage interface with Health Authorities for key projects and meetings; Advise internal customers on regulatory issues; Coordinate regulatory submissions and responses to Health Authorities; Operate independently to plan operations within area of responsibility
Seniority
Senior Manager, strategic planning & execution