Medical Advisor
CurrentResponsible for - Undertaking evaluation and critical assessment of complex submissions of clinical data provided by sponsors and providing recommendations on whether the Essential Principles are met for medical devices subject to pre- or post- market review- Preparing concise written reports detailing the outcome of the evaluation and detailing recommendations in a logical and scientific manner, including deficiencies identified- Evaluating instructions for use for medical devices to determine whether all relevant information is adequately communicated and recommending changes where appropriate- Assessing applications for the supply of unapproved medical devices and making administrative decisions in that regard- Assisting the Director with other tasks as required- Contributing to the development and revision of regulations, technical and administrative procedures, guidelines, SOPs, policies, new work processes and on the adoption of guidelines and standards within MDB and TGA- Assisting with the training and mentoring of other medical officers and scientific/technical assessors across the range of tasks performed at their respective levels.- Addressing product recalls including liaison with sponsors and other external stakeholders- Special Access Scheme and Authorised Prescriber