• • 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 3^rd 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

• • 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.

• • 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..

Irvine or Valencia, California

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.