What are the responsibilities and job description for the Director, Regulatory Affairs position at AVITA Medical Americas, LLC?
Description
AVITA Medical® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL® System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells.
We believe that patients are at the heart of everything we do, our employees are the lifeblood of AVITA Medical, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.
Position Summary: The Director of Regulatory Affairs plans, executes, and oversees daily activities associated with Avita Medical Global Regulatory Affairs. Primary responsibilities include the coordination and assurance of regulatory compliance and product approvals.
Key Responsibilities:
- Direct and lead the daily activities associated with Global Regulatory Affairs programs for Avita Medical.
- Development and on-going maintenance of the company’s global product licenses and approvals in the United States, Europe, and Asia Pacific.
- Responsible for ensuring that all regulatory submissions, product Technical Files and Design Dossiers are current, accurate, and compliant to applicable standards.
- Develop systems and processes for assessing and reporting changes to regulations impacting Avita Medical products.
- Maintain database of current global regulatory standards.
- Responsible for global labeling review and approval.
- Manage external relationships with FDA, EU Notified Body and 3rd party entities used in obtaining global product licenses and approvals.
- Develop, plan and implement regulatory strategies for global licenses and approvals of Avita Medical products.
- Monitor changes to global regulations impacting Avita Medical products.
- Plan, assign, and manage day to day tasks of Regulatory Affairs staff.
Requirements
- 8-10 years of direct experience in Global Medical Device Regulator Affairs
- Direct experience with US FDA, European Medical Device Regulation, Australian Regulatory Guidelines for Medical Devices. Experience in managing medical device approvals in China and Japan desired.
- Strong verbal and written communication skills.
- Strong management, interpersonal, and team-building skills.
- Proficiency with Microsoft Word, Microsoft Excel and adaptable to various technical business applications (cloud-based).
- Minimum Bachelor’s degree in science or related discipline required.
