Expertise

Paul L Clark has over 20 years’ experience in the international MedDev industry, working in various capacities including regulatory affairs, quality management, clinical research, operations and country management. He has worked for regulatory agencies in Australia, Canada, US and Europe, and as a senior manager with start-up and medium sized MedDev companies. He has a unique skill set that combines his regulatory, quality and clinical background with proven commercial experience, including the successful launch of MedDev products in the ANZ market. His experience spans a range of active and non-active MedDev technologies, including renal, cardiovascular, ophthalmic, drug delivery, gastrointestinal, intensive care, wound care, active implantables and monitoring devices. In addition to his current role as consultant and advisor to a number of MedDev clients, he is on the Commercialization Advisory Board for Endogene Ltd. His previous roles in the MedDev industry include:

• Director of ANZ, NxStage Medical, Melbourne, Australia
• Director of Regulatory & Clinical Affairs, NxStage Medical, Boston, MA, USA
• Clinical, Regulatory & QA Manager, Norwood Abbey Ltd, Melbourne, Australia
• QA/RA/Clinical Manager, Q-Vis Ltd, Perth, Australia
• Lead ISO13485/MDD auditor with TUV SUD (Product Services) Boston, MA, USA
• Medical Device Reviewer, Medical Devices Bureau, Ottawa, Canada
• Medical Device Reviewer, TGA, Canberra, Australia

Paul L Clark is a dual Australian and US Citizen and has a B.App.Sc in Medical Biophysics from Swinburne University of Technology in Melbourne, Australia.