Director/Senior Director, Regulatory Affairs
3 weeks ago
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 HR@avitamedical.com.
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 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
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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