Are you an auditor or inspector with experience in regulatory audits of medical technology manufacturing? We are looking for a Senior Auditor and MDSAP Assessor who will provide leadership in delivering the Therapeutic Goods Administration (TGA) participation in the international Medical Device Single Audit Program (MDSAP). The role will include compliance with regulatory requirements, product, process, and quality management system standards and provide recommendations on assessment outcomes as needed. The Senior Auditor and MDSAP Assessor will manage the ongoing implementation of the program, which will include significant internal and external stakeholder engagement and travel as necessary. The key duties of the position include Duties include but are not limited to: Supervising a team of staff, ensuring high quality outputs including that employees maintain a high level of specialist, professional and/or technical expertise. Monitor and manage progress of program activities against set timeframes to meet milestones and deliverables Plan, conduct, and document results of discussions with external stakeholders in such a manner as to achieve assessment objectives, determining the accuracy of information from interviewees and potential indicators of further follow-up action. Undertake head office assessments of MDSAP Auditing Organisations and witness audits of Auditing Organisations conducting MDSAP audits of medical device manufacturers. Undertake audits and assessments of quality management systems for the manufacture of medical devices in accordance with regulatory requirements and applicable international standards Research, interpret and apply legislation, regulatory guidelines, international standards and best-practice when undertaking audits Provide timely, professional and accurate advice on complex issues relating to regulation, interpretation of legislation, guidelines, best-practice, emerging technologies, and fields of expertise Use judgement and expertise, to ensure all recommendations are governed by the application of the Australian therapeutic goods regulatory framework and state of the art technical standards or other best-practice guidelines Provide leadership, mentoring and guidance in technical and regulatory matters to achieve branch objectives Prepare, review and deliver detailed technical reports and presentations, ensuring suitability to the audience Engage and manage both internal and external stakeholders through change, resolving conflict and managing sensitivities Manage record keeping in accordance with the regulatory and legislative requirements and whole of- government policy and standards.
