APS 6 - Medical Device Incident Investigator

About the company

The Medical Devices Branches of the TGA evaluate medical devices, including in vitro diagnostic tests, and monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance.

About the opportunity

This APS 6 role sits within the Devices Post Market Monitoring Section (DPMMS). You will be responsible for undertaking risk assessment and Investigation of adverse event reports associated with the use of medical devices.

Duties

• Undertaking 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 delegation where appropriate.
• Undertaking under limited direction, risk assessment and Investigation of adverse event reports associated with the use of medical devices.

• Providing detailed technical engineering/biocompatibility or clinical expertise in the area of medical device technology, including anticipating problems and contributing to issues management
• Coordinating and managing multi-component assessments, investigations and reviews requiring liaison with internal and external professionals
• Implementing a risk management approach to support regulatory decisions
• Dealing with complex issues and managing stakeholders
• Writing statements for publication on the safety and performance of medical devices on TGA's website
• Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.

Skills and Experience

• Relevant qualifications in science related field of studies or biomedical engineering
• Knowledge of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and other legislative instruments and guidelines
• Experience in investigating adverse events associated with the use of therapeutic goods.
• Ability to interpret, draft and review policy and procedural documentation.
• Technical expertise and experience relevant to the use, assessment, manufacture, design, testing and monitoring of medical devices.
• Strong communication skills including ability to prepare clearly articulated reports and briefs on the subject matter.
• Sound judgment, attention to detail and organisational skills and ability to take responsibility for work, prioritising tasks and producing quality outputs to meet tight deadlines.

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on jmurphy@hpgconnect.com for a confidential discussion.

( SK927795A )