Terrance (TJ) Thiel
TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices.
TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. He has provided due diligence activities for company acquisitions regarding the target’s business viability, quality system status and regulatory position. TJ’s expertise also supports businesses to create, revise and execute quality systems that are efficient and understood by all employees to provide compliance in a consistent and concise manner.
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