Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device (Hybrid)

AbbVie

Senior Manager of Regulatory Affairs leading US and Canada strategic planning for aesthetics devices. Responsible for lifecycle management, Health Authority interface, and regulatory submission oversight for assigned products or indications within a therapeutic area.

Responsibilities

Develop and execute US and Canada regulatory strategy and tactical planning for assigned products
Lead product lifecycle activities including post-approval requirements and Health Authority requests
Manage FDA interface and coordinate regulatory submissions and meeting preparation
Supervise preparation and review of regulatory submissions per US and Canada requirements
Advise cross-functional teams on regulatory and FDA compliance issues

Requirements

Advanced degree (PharmD, PhD, MS) or regulatory certification
5+ years regulatory, R&D, or equivalent industry experience
Medical device industry experience
Digital health or software experience
Proven ability to implement affiliate regulatory strategies
Government regulatory agency interface experience
Complex matrix environment experience

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Vacancy posted 2 days ago

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