APS 6 - Medical Device Assessor

About the company

The Medical Devices Authorisation Branch of the TGA evaluates medical devices, including in vitro diagnostic medical devices (IVDs), and monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance

About the opportunity

The Devices Applications Section (DAS) within the Medical Devices Authorisation Branch is responsible for pre-market assessment of applications for inclusion of medical devices (IVD and non-IVD) and applications for listing and registration of other therapeutic goods (OTG) in the ARTG.

Duties

• Undertake desk top regulatory and technical assessments of pre-market inclusion applications for medical devices (including IVDs) and OTGs in the ARTG, interpret and apply legislation, regulatory guidelines, international standards and best-practice, collating expert advice relevant to the assessment, preparing clear statements of reason based on the investigation findings, matters of fact, and knowledge of the regulations, and exercising delegation where appropriate.
• Provide timely technical/professional advice to internal and external stakeholders.
• Be responsible for record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols.
• Participate in providing quality improvement in regulatory processes and reform in key areas, according to government priorities.
• Positively contribute to representing the TGA at various internal and external meetings as necessary to fulfil the TGA's functions as the national regulator of the therapeutic goods as required.
• Contribute to broader organisational objectives by undertaking other tasks as required.

• Contribute to a positive, collaborative, and diverse workplace culture in line with APS Code of Conduct and Care Values.

Skills and Experience

• Relevant Qualifications in medical science, or health related field of studies.
• Experience in regulatory and technical assessments and reporting through evaluation of technical documentation and data in the field of medical devices will be highly regarded.
• Ability to maintain knowledge of relevant legislative and reporting requirements, Australian and International standards, quality assurance procedures and best practice models
• Ability to apply comprehensive work knowledge, precedent and established legislation, policy, procedures, and guidelines to situations involving a high level of complexity and sensitivity which require considerable interpretation and analysis
• Ability to provide significant and detailed advice on regulatory issues related to medical devices (including IVDs) and OTGs
• Ability to interpret, draft and review policy and procedural documentation

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )