Director Of Regulatory Affairs

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 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 Regulatory 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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.