US & Canada Regulatory Strategy Lead – Medical Devices

AbbVie; California; On-site; USD 150,000 - 190,000; Full time

Job summary

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to shape regulatory strategies for US and Canada markets. You will lead lifecycle activities, interface with FDA, and advise cross-functional teams on regulatory issues to enable timely product approvals and compliance.

The role requires an advanced degree or regulatory certification and 5+ years in regulatory or related fields within the medical device space, including digital health software.

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification.
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space.
• Experience with digital health/software.
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Responsibilities

• Develop and implement US & Canada regulatory strategic and tactical planning (RSTP) for on-market products or those in development.
• Lead total product lifecycle activities including change assessments, post-approval requirements, and Health Authority interactions.
• Manage interface with Health Authority (FDA) for key projects and coordinate FDA meeting briefs.
• Advise internal customers on Regulatory/FDA issues across functions (Public Affairs, Clinical Development, Legal, Commercial).
• Operate independently with escalation when needed and plan assignments within area of responsibility.
• Coordinate, prepare and review regulatory submissions to ensure compliance with US/Canada requirements.
• Demonstrate understanding of US & Canada regulations, guidance, and industry practices to support organizational goals.
• Present regulatory information to cross-functional teams and align with Quality Dossier Program (QDP).
• Work in compliance with regulations, company policies, and regulatory product strategy.

Skills

Regulatory strategy

FDA liaison

Stakeholder management

Negotiation skills

Communication skills

Education

Advanced degree or regulatory certification

Job description

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to shape regulatory strategies for US and Canada markets. You will lead lifecycle activities, interface with FDA, and advise cross-functional teams on regulatory issues to enable timely product approvals and compliance.

The role requires an advanced degree or regulatory certification and 5+ years in regulatory or related fields within the medical device space, including digital health software.