Assistant Director in the Devices Emerging Technology and Diagnostics Section
Therapeutic Goods Administration
Rebecca Bateson is an Assistant Director in the Devices Emerging Technology and Diagnostics Section, currently serving as the project lead responsible for the introduction of the suite of reforms known as the personalised medical devices framework. Rebecca has a strong background in stakeholder engagement with the TGA, having previously managed the Medical Devices Information Unit and the Devices Secretariat. Her work has included developing legislative instruments, guidance for stakeholders and resources for both internal and external stakeholders to improve day-to-day business at the TGA. In 2016, Rebecca was awarded the Department’s Australia Day Award for Service in recognition of her commitment to stakeholder engagement.
Rebecca’s team includes staff with backgrounds in biomechanical engineering and allied health. Together the personalised medical devices team are working to contact over 10,000 individually impacted stakeholders to bring the regulatory requirements of the personalised medical devices framework to their attention and assist them with achieving compliance with their obligations. The team are also members of the International Medical Device Regulator’s Forum’s Personalized Medical Devices Working group, developing guidance that can be used to harmonise the requirements for personalised medical devices with jurisdictions around the world.