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.
- 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
- 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
- Degree in engineering or physical/biological sciences
- 3+ yrs of professional work experience in regulatory affairs
- Experience in Class III medical device industry (preferred)
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.