Regulatory Affairs Associate - Medical Devices

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.

Duties

• 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

Culture

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.