About the position
The Director/Senior Director of Regulatory Affairs at Avita Medical is a pivotal role responsible for planning, executing, and overseeing the daily activities associated with Global Regulatory Affairs. This position requires a seasoned professional who can provide guidance and mentorship to the Regulatory Affairs team while acting as the Regulatory leader in the Medical, Legal, and Regulatory Review process. The role involves the review, approval, and dissemination of advertising and promotional materials, ensuring compliance with applicable regulatory requirements across all products. The successful candidate will be accountable for the day-to-day operations of the Regulatory Affairs team, managing external relationships with regulatory authorities such as the FDA, EU Notified Body, and other third-party regulatory bodies. In addition to overseeing the regulatory review process, the Director/Senior Director will develop, plan, and implement regulatory strategies for global licenses and approvals. This includes monitoring changes to global regulations that may impact Avita Medical products and providing regulatory assessments of product design and manufacturing changes. The primary objectives of this role include the submission and approval of marketing applications within established project timelines, maintaining global product licenses and approvals in the United States, Europe, and Asia Pacific, and ensuring that all U.S. advertising and promotional materials comply with relevant regulatory standards and guidelines. Furthermore, the Director/Senior Director will be responsible for developing systems and processes for assessing and reporting changes to regulations that affect Avita Medical products.
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
- 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
Requirements
- 10-15 years of specific and direct experience in Regulatory Affairs
- Demonstrated success in obtaining approvals from 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
