About the company

The Medical Devices Surveillance Branch of the TGA is responsible for the post market activities of medical devices, including in vitro diagnostic medical devices (IVDs), and monitoring them throughout their lifecycle to ensure they continue to meet appropriate standards. The Device Post Market Monitoring Section (DPMMS) within the Medical Devices Surveillance Branch is responsible for managing several post market regulatory programs

About the opportunity

The APS6 Compliance Assessor is 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.
• 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 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

Key Capabilities

• Provide timely, quality, and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge
• Manage record keeping in accordance with the regulatory requirements and whole of- government policy and standards
• Provide inputs and advice to the policy development and business improvement related to medical devices when required and where appropriate
• Write statements for publication on the safety and performance of medical devices on TGA's website
• Represent the TGA at education seminars, conferences, and workshops.

Mandatory Qualifications

Material scientists/engineers - preferably with experience with medical devices or in hospital/health service or Toxicology scientists - preferably with experience with medical devices or in hospital/health service

How to Apply

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

( SK927795A )