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

Senior Manager overseeing US and Canada regulatory strategy for aesthetics devices at AbbVie. Develops and executes regulatory plans for approved and in-development products while managing FDA interactions and cross-functional coordination to ensure compliance and commercialization success.

Responsibilities

• Develop and implement US and Canada regulatory strategy and tactical planning for assigned products
• Lead product lifecycle activities including change assessments, post-approval requirements, and Health Authority responses
• Manage FDA interactions and serve as primary liaison for key meetings and regulatory submissions
• Coordinate preparation and review of regulatory submissions meeting US and Canada requirements
• Advise internal stakeholders on regulatory and FDA matters across multiple departments

Requirements

• Advanced degree (PharmD, PhD, MS) or regulatory certification
• 5+ years regulatory, R&D, or equivalent industry experience
• Medical device industry experience required
• Digital health or software experience
• Proven ability implementing affiliate regulatory strategies
• Experience interfacing with regulatory agencies such as FDA
• Strong negotiation, problem-solving, and consensus-building skills