Regulatory Strategy Lead, US & Canada – Devices

AbbVie; Illinois; Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to lead regulatory strategy and execution for on‑market and development products across the US/Canada. You will align with GRPT, manage FDA interactions, and drive submissions while guiding cross-functional teams to meet regulatory requirements.

The ideal candidate has 5+ years in regulatory affairs within the medical device space, with digital health experience and strong negotiation and

Qualifikationen

• 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.

Aufgaben

• Leads regulatory strategy development for US & Canada and supports GRPT.
• Coordinates regulatory submissions and responses to Health Authorities.
• Manages interface with FDA for key projects and meetings.
• Advises internal customers on Regulatory/FDA issues across functions.
• Operates independently with minimal direction and clear decision-making.
• Ensures timely completion of regulatory filings and compliance with US/Canada requirements.
• Presents regulatory information to cross-functional teams.
• Ensures compliance with regulatory standards and QDP guidelines.

Kenntnisse

Regulatory strategy

Medical devices

Digital health/software

Government liaison

Cross-functional collaboration

Negotiation

Communication skills

Ausbildung

Advanced degree (PharmD/PhD/MS)

Jobbeschreibung

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to lead regulatory strategy and execution for on‑market and development products across the US/Canada. You will align with GRPT, manage FDA interactions, and drive submissions while guiding cross-functional teams to meet regulatory requirements.

The ideal candidate has 5+ years in regulatory affairs within the medical device space, with digital health experience and strong negotiation and