Regulatory Strategy Lead, US & Canada - Aesthetics Devices

AbbVie; New Jersey; On-site; USD 140,000 - 200,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to drive regulatory strategy for US & Canada markets. You will lead regulatory lifecycle activities, interact with FDA teams, and coordinate with Clinical, Legal, and Commercial stakeholders to ensure compliant filings and timely submissions.

The role requires advanced regulatory expertise, device regulatory experience, and strong cross-functional leadership to translate business needs into

Qualifications

• Advanced degree or regulatory certification.
• 2+ experience in regulatory, R&D, or equivalent.
• Experience in medical device space and digital health/software.
• Experience interfacing with government regulatory agencies.
• Experience in complex, matrix environments.

Responsibilities

• Develop and implement US & Canada regulatory strategy for Aesthetics Device products.
• Lead lifecycle activities and regulatory submissions.
• Coordinate with FDA and internal teams for regulatory inquiries and meetings.
• Advise cross-functional teams on regulatory/FDA issues.
• Ensure compliance with US/Canada regulatory requirements and guidelines.
• Present regulatory information to cross-functional teams.

Skills

Negotiation skills

Regulatory strategy

Communication skills

Problem solving

Cross-functional collaboration

Education

Advanced degree (PharmD/PhD/MS) or Regulatory certification

Tools

Regulatory submissions systems

Job description

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to drive regulatory strategy for US & Canada markets. You will lead regulatory lifecycle activities, interact with FDA teams, and coordinate with Clinical, Legal, and Commercial stakeholders to ensure compliant filings and timely submissions.

The role requires advanced regulatory expertise, device regulatory experience, and strong cross-functional leadership to translate business needs into