Senior Regulatory Specialist

2 days ago

Canberra, ACT, Australia beBeeImplementation Full time $111,940 - $127,670
About the Role

The Unique Device Identification (UDI) Project is a strategic initiative responsible for implementing a key medical device reform in Australia. This reform aims to establish and facilitate the adoption of a UDI system, enabling the tracking of high-risk implanted devices from supply through to implantation and use.

To deliver this initiative, the project team undertakes a range of activities, including:

  • Implementing policy related to new regulations
  • Building a database for storing UDI data
  • Engaging with sponsors of medical devices
  • Integrating UDI into related processes at the TGA
  • Supporting adoption by the healthcare sector

Skillset Required:

The ideal candidate will possess strong analytical, communication, and project management skills, with experience in:

  • Regulatory affairs and policy implementation
  • Database development and management
  • Stakeholder engagement and collaboration
  • Process improvement and integration
  • Healthcare industry knowledge

What We Offer:

This role presents an exceptional opportunity to contribute to a significant healthcare reform and develop valuable skills in regulatory affairs, project management, and stakeholder engagement.

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