Regulatory Strategy Lead - US & Canada, Aesthetics Devices

Regulatory Jobs; Irvine (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device in Irvine to shape regulatory plans for on-market and development programs. You will align with GRPT, coordinate FDA interactions, and drive submissions across product lifecycles.

The role demands an advanced degree or regulatory certification, 5+ years in regulatory/R&D, and experience with medical devices and digital health. Strong leadership and cross-functional influence are essential.

Qualifications

• Advanced degree or regulatory certification required.
• 5+ years regulatory, R&D, or equivalent industry experience.
• Experience in medical device space.
• Experience with digital health/software.

Responsabilités

• Lead US/Canada regulatory strategy and planning for aesthetics devices.
• Coordinate regulatory submissions and interface with FDA.
• Advise cross-functional teams on regulatory issues and timelines.
• Drive lifecycle activities including post-approval and change assessments.

Connaissances

Negotiation skills

Communication skills

Problem solving

Consensus building

Formation

Advanced degree or regulatory certification

Description du poste

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device in Irvine to shape regulatory plans for on-market and development programs. You will align with GRPT, coordinate FDA interactions, and drive submissions across product lifecycles.

The role demands an advanced degree or regulatory certification, 5+ years in regulatory/R&D, and experience with medical devices and digital health. Strong leadership and cross-functional influence are essential.