APS 6 Medical Device Assessor & Investigator

Benefits

Gain unique experience completing risk assessments and investigations on behalf of the Medical Devices Authorisation and Surveillance Branches of the TGA.

About the company

The Devices Post Market Monitoring Section of the TGA undertakes risk assessments of all reports entered into the Incident Report Investigation Scheme (IRIS) database and conducts in-depth investigations if necessary. Findings are utilised to advise advise government, industry, consumers, and media bodies.

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

About the opportunity

12-Month contracts have become available to be APS6 Medical Device Assessors & Investigators for the TGA.

Assessors will be 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.

Investigators will be responsible for undertaking risk assessment and investigation of adverse event reports associated with the use of medical devices. This involves the collation and assessment from various sources such as regulator reports, unresolved or increasing recalls, government reports or publications in journals or newspapers.

Duties might include:

• Undertake assessments of complex technical documentation and data, collating expert advice relevant to the assessment, preparing a clear statement of reasons based on the investigation
• Coordinate and manage multi-component assessments, investigations and reviews requiring liaison with internal and external stakeholders
• Contribute to post-market reviews of existing ARTG entries for IVD medical devices
• Prepare ministerial briefs, web statements, or media responses relating to the reviews that have been undertaken
• 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.

Skills and Experience

• Clinical background (clinical nurses, engineers, medical scientists, toxicology, material scientists)
• Industry experience working with medical devices highly desirable
• Experience in a pathology laboratory, biomedical science or IVD industry knowledge
• Ability to review and assess complex technical data
• Competent with technical report writing
• Confident and effective communicator

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.