Director/Senior Director, Regulatory Affairs – Irvine or Valencia

Director/Senior Director, Regulatory Affairs – Irvine or Valencia

Position summary:

  • Plans, executes, and oversees daily activities associated with Global Regulatory Affairs. Primary responsibilities include guidance and mentoring of Regulatory staff and acting as Regulatory leader in the Medical, Legal and Regulatory Review process including review, approval, and dissemination of advertising and promotional materials. If you qualify and are interested in this position, please email your resume to [email protected].

Essential duties and responsibilities:

    • Regulatory review and approval of advertising and promotional material
    • Provide creative guidance from a Regulatory perspective on the development of product messages and materials.
    • Accountable for day-to-day guidance of Regulatory Affairs team
    • Manage external relationships with FDA, EU Notified Body and 3rd party regulatory authorities
    • Develop, plan, and implement regulatory strategies for global licenses and approvals
    • Monitor changes to global regulations impacting Avita Medical products
    • Provide regulatory assessments of product design and manufacturing changes

Primary objectives:

    • Submission and approval of marketing applications within established project time-lines.
    • Maintenance of global product licenses and approvals in the United States, Europe, and Asia Pacific.
    • Ensure U.S. advertising and promotional materials comply with applicable regulatory requirements, standards, and guidelines across all products
    • Develop systems and process for assessing and reporting changes to regulations impacting Avita Medical products.

Minimum job requirements:

    • 10-15 years of specific and direct experience in Regulator Affairs
    • Demonstrated success approvals of US FDA, European MDR, and Australian Regulatory marketing approvals for Medical Devices including 510(k), PMA, CE Mark for multiple device classifications
    • Impeccable verbal and written communication skills.
    • Strong management, interpersonal, and team building skills..

Position Location

Irvine or Valencia, California

Information Security Compliance

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner.  

AVITA Medical is committed to protecting the security of its information and information systems.  As such, each role within AVITA Medical must demonstrate the same commitment to information security.

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