Director, Global Regulatory Affairs – Devices & Combination Products

Regulatory Jobs; Irvine (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Director of Regulatory Affairs for Device products to lead regulatory strategy across development and marketed devices. You will supervise submissions, interact with health authorities, and guide cross-functional teams to align with global regulatory requirements.

The role requires a strong track record in device regulatory affairs, leadership of diverse teams, excellence in communication, and the ability to influence policy while driving timely regulatory

Qualifications

• 10 years device and combination product experience with 2+ years demonstrated leadership.
• Experience developing and implementing successful global regulatory strategies.
• Experience interfacing with Health Authority and working in complex and matrix environments.
• Strong oral and written communication skills.
• Note: Travel knowledge or willingness to travel may be needed

Responsibilities

• Lead global RA Device team in developing regulatory strategies for development-stage and marketed products.
• Manage content of global regulatory dossiers and reviews of submissions to authorities.
• Advise internal teams on regulatory strategies across RA, R&D, and Operations.
• Drive regulatory policy and strategy across the organization and interface with health authorities.
• Provide leadership and mentorship within the RA Device group.

Skills

Regulatory strategy

Leadership

Regulatory affairs

Communication skills

Team management

Education

Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

Advanced degree preferred

Certification a plus

Tools

eCTD tools

EDMS applications

Job description

AbbVie in Irvine, CA is seeking a Director of Regulatory Affairs for Device products to lead regulatory strategy across development and marketed devices. You will supervise submissions, interact with health authorities, and guide cross-functional teams to align with global regulatory requirements.

The role requires a strong track record in device regulatory affairs, leadership of diverse teams, excellence in communication, and the ability to influence policy while driving timely regulatory