Regulatory Consultant with a global perspective.
Previous roles as Director of Devices Evaluation for Australian Therapeutic Goods Administration, in academic research and in commercial product development.
More than 30 years in the medical devices industry in Europe, Australia and Asia and service to ISO and the AHWP has developed a wide network and a truly global perspective on medical devices regulation and international harmonization.
A passionate educator with continuing and active involvement in University teaching and industry training.
Regulatory submissions, post market compliance, biomaterials, biocompatibility (active participant in ISO 10993 standards development for 20 years), ISO 14971 risk management. Strong interests in international harmonization and in medical device and IVD regulation in Asia (China, Japan, Korea, ASEAN and Australia/NZ).