Regulatory Affairs Associate - Medical Devices (37262) North Shore, Australia
About the company
An established medical equipment supplier to the medical and allied health sector in Australia. A broad product range and a global reach.
About the opportunity
This is a newly created position to provide support to the Regulatory Affairs Manager across the full regulatory function. You will gain experience working with a broad product portfolioof Class I - III medical devices.
Excellent opportunity for a a junior RA Associate to further develop their skillset and work across all areas of Regulatory with the support and guidance of an experienced Regulatory Affairs Manager.
- Provide support with compiling dossiers for regulatory submission to the TGA/Medsafe and other associated bodies including AICIS
- Maintain regulatory compliance of all products and ensure records are up to date
- Review and approve advertising and promotional materials ensuring compliance with advertising Codes.
- Evaluate proposed product, labelling and manufacturing changes for regulatory filing solutions.
Skills and Experience
- 2+ years’ experience for Regulatory Affairs Associate
- Tertiary qualifiaction in scientific discipline
- Previous experience with Class I and Class II medical devices
- Knowledge of TGA and Medsafe requirements for Medical Devices
- Experience with analysis and interpretation of regulatory documentation and technical writing
- Excellent communication and negotiation skills
- Keen to learn and further develop skills and knowledge in regulatory affairs
A small company with a strong team spirit. Supportive and collaborative working environment and patient focused.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager – Regulatory Affairs & Quality Assurance on +61 2 8877 8718 for a confidential discussion.