Regulatory Affairs Associate - Medical Devices (37262) North Shore, Australia

Salary: super

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.

 

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