Sr RA Specialist

Overview

Primary Function

The Sr. Regulatory Affairs Specialist is a key contributor to the company's regulatory group focused on support for AVITA Medical's regenerative products. The role includes providing early guidance, review, and approval of submission-related documentation.

Duties/Responsibilities

• RA lead for all activities associated with changes to the on-market product (supplier, design, manufacturing, etc.)
• Assesses changes for any regulatory action required in the US, EU, AU/NZ, and Japan
• Prepares FDA submissions (PMA supplements) to ensure timely approvals and market release for product changes
• Establish and manage documented procedures for the creation and management of IFUs, procedure guides, and product labels
• Define Labeling content in compliance with US and international regulatory requirements
• Reviews and approves product testing and other submission related deliverables to ensure regulatory compliance
• Collaborates with new product development team and provide regulatory support as required
• Reviews and Revises SOPs, and other company and departmental procedures to ensure quality system compliance
• Participates in device development design reviews and risk management activities
• Establishes and maintains relationships within AVITA Medical quality, R & D, and operations teams

Special Knowledge/Skills

• Experience in the development of FDA submissions for a medical device (IDE, 510 (k), HDE, PMA, or PMA supplements)
• Experience in reviewing and/or approving engineering reports/data or changes
• Ability to process complex technical reports into understandable summaries
• Ability to effectively manage multiple projects and priorities

Experience/Education

• Degree in engineering or physical/biological sciences
• 3+ yrs of professional work experience in regulatory affairs
• Experience in Class III medical device industry (preferred)