Director of International Projects
Therapeutic Goods Administration
Rachel Croome is the Director of International Projects for the Medical Devices Authorisation Branch of the Therapeutic Goods Administration, or TGA.
Rachel looks after international projects, including updates to international agreements in the devices sector, supporting TGA participation in international regulatory harmonisation efforts through the International Medical Device Regulators Forum (IMDRF), and the facilitating use of overseas regulatory approvals to meet Australian regulatory requirements.
As part of her role Rachel manages the Medical Device Information Unit, who provide individualised phone and email support for the medical devices sector in complying with Australia’s medical device regulations, as well as information and support for consumers, health professionals and the health sector.
Rachel also undertakes various projects, working on a number of legislative and regulatory reforms since she commenced with the TGA in 2012. A current project is the review of low risk medical devices, which includes reviewing the regulatory status of products use for and by people with disabilities. .