El2 - Senior Auditor And Mdsap Assessor - Devices Manufacturing Quality Section

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.
Eligibility
To be eligible for employment with the Department of Health, Disability and Ageing, applicants must be an Australian citizen at the time an offer of employment is made.
An applicant's suitability for employment with Health will also be assessed through a variety of pre-employment check processes, such as:
Satisfactory completion of a criminal history check, and where relevant, a Working with Children and Vulnerable People Check,
Completion of a medical declaration and pre-employment medical (where required),
Providing evidence of qualifications (where required), and
Obtaining and maintaining a security clearance at the required level.
The candidate must promptly disclose and effectively manage any potential conflict of interest (whether real or perceived), including financial interests, arising from their APS employment, particularly concerning medical devices and interactions with industry. They must also disclose any significant personal interests that may impact their APS duties, both prior to and throughout their tenure.
Notes
Applications close 8 September 2025 at 11:30pm AEST.
Applicants are asked to quote reference number 25-MDPQDIV-29566 to assist when making an enquiry.
Employees perform their duties at one of the Department of Health, Disability and Ageing offices, in the locations specified in this advertisement. Remote working is possible and is negotiated with your manager on commencement. Flexibility can be negotiated with your manager to balance your personal and professional needs with the needs of your role and business area.
This recruitment process is being used to fill both ongoing and non-ongoing positions. Non-ongoing positions will be offered on a specified term basis for an initial period of up to 12 months with the possibility of being extended (this will not exceed a total of 24 months in the same or similar role).
Getting to know the Department of Health, Disability and Ageing
The Department of Health, Disability and Ageing is focused on achieving better health and wellbeing for all Australians. If you would like to join our team, and can meet our job requirements, we invite you to apply for a position with us to build better health, better care and better quality for all Australians. The department is committed to providing an inclusive and diverse workplace where the experiences, skills and perspectives of all individuals are valued. We actively encourage applications from diverse backgrounds and cultures, so we can better represent the community we serve. The department welcomes applications from Aboriginal and Torres Strait Islander people, people with disability, mature age people, people who identify as LGBTI+, and people with parenting and/or caring responsibilities.