Originally hailing from Ireland, with a BSc in Applied Science (Physics and Chemistry), Aileen came to Australia in 2001 with experience in the chemical and cosmetic Industries in Dublin. Moving into Quality and Regulatory roles in Analytical and Pharmaceutical Industries, she then embarked on a career in Diagnostics, where she has been for over 17 years now. In her current position as Snr RA Manager in Abbott, she leads a team across Point of Care, Molecular and Core Diagnostics, where she advises on regulation changes and their impacts to the local business. She also contributes and collaborates with global teams in the US and Europe on technical dossiers for submissions to the Australian regulator, TGA.
She is a member of various working groups in Australia, mostly working on aspects of new or changing regulations within the Australian regulatory framework and processes, including IT, SaMD, and MDSAP. She is the current Chair of the Technical and Regulatory Standing Committee (TARSC), for the Australian Pathology Industry Association, Pathology Technology Australia (PTA) and a member of the MTANZ Regulatory Advisory Group. She is passionate in ensuring the patient and patient safety is the focus of all aspects of regulations and enjoys working in a collaborative environment with Industry and regulators alike, to ensure this goal is achieved.
Aileen is based in Sydney, Australia.