Regulatory Strategy Lead – US & Canada, Aesthetics Devices

BioSpace; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Paid time off

401(k) plan

Long-term incentive programs

Job summary

AbbVie in Irvine, CA seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to shape regulatory strategy, oversee submissions, and coordinate with FDA for on-market and development programs. You will align regulatory planning with business goals and cross-functional teams.

The role requires advanced degrees or regulatory certification with 5+ years in regulatory affairs, including medical devices and digital health, across US/Canada.

Qualifications

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

Responsibilities

• Lead US & Canada regulatory strategy for aesthetics device portfolio.
• Coordinate regulatory submissions and responses to Health Authorities.
• Interact with FDA and other regulatory bodies as primary liaison.
• Advise cross-functional teams on regulatory implications and timelines.
• Ensure compliance with US/Canada regulatory requirements and QDP.

Skills

Negotiation skills

Effective communication

Message delivery under pressure

Education

Advanced degree (PharmD/PhD/MS)

Regulatory certification

Job description

AbbVie in Irvine, CA seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to shape regulatory strategy, oversee submissions, and coordinate with FDA for on-market and development programs. You will align regulatory planning with business goals and cross-functional teams.

The role requires advanced degrees or regulatory certification with 5+ years in regulatory affairs, including medical devices and digital health, across US/Canada.