EMPLOYMENT

Devices Post Market Monitoring Section (DPMMS) is a dynamic, multidisciplinary team seeking enthusiastic professionals who can undertake complex investigations of medical device incidents. Investigations are based on signals from many sources such as reports in the TGA database, information from other regulators, unresolved or increasing number of recalls, government and publications in journals or newspapers. The APS 6 Medical Device Investigator is responsible for undertaking analysis, risk assessment, case management, triage and investigation of medical device adverse events, as well as undertaking general or specialist assessment of submissions and technical documentation received. The key duties of the position include Undertake assessment of the technical documentation and data, collating expert advice relevant to the assessment, preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations, and exercising decision making powers where appropriate. Undertaking under limited direction, risk assessment and investigation of signals associated with medical devices. Coordinating and managing multi-component assessments, investigations, reviews and other projects requiring liaison with internal and external professionals. Implementing a risk management approach to support regulatory decisions, including anticipating problems and contributing to issues management. Dealing with complex issues and managing stakeholders. Preparing briefs, meeting records, ministerial correspondence, guidelines and consultation documents, and providing timely and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge. Providing advice, assistance and decision making in relation to regulatory action and administrative law processes. Managing record keeping in accordance with the regulatory requirements and whole of- government policy and standards. Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.