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

Senior Manager leading US and Canada regulatory strategy for aesthetics devices at AbbVie. Responsible for developing and implementing regulatory plans for marketed and development-stage products, managing FDA interactions, and ensuring compliance with applicable regulations.

Responsibilities

• Develop and execute US and Canada regulatory strategy for assigned products and indications
• Lead product lifecycle activities including change assessments, post-approval requirements, and authority inquiries
• Manage FDA interface for key projects and coordinate meeting preparations and submissions
• Prepare and supervise regulatory submissions ensuring compliance with US and Canada requirements
• Advise internal stakeholders on regulatory and FDA issues across clinical, legal, and commercial functions

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 product experience
• Experience interfacing with regulatory agencies (FDA preferred)
• Proven ability to implement affiliate regulatory strategies
• Excellent negotiation, problem-solving, and communication skills