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Form of work
SalaryThis section within this Federal Government agency undertakes post-market reviews of Medical Devices. The reviews include assessment of technical data, complex monitoring, analysis, and investigations for post market regulatory programs for Medical Devices, and the implementation of review outcomes.
The branch is responsible for monitoring Medical Devices, including in vitro diagnostic devices (IVD), throughout their lifecycle to ensure they meet appropriate standards.
About the role
The APS6 Reviewer is responsible for co-ordinating reviews and undertaking assessments of submissions in relation to the post-market reviews of Medical Devices.
Duties and responsibilities:
- 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 signals associated with Medical Devices.
- Providing detailed in vitro diagnostic, sequence alignment, and antigen/protein modelling expertise in the context of Medical Device technology, including anticipating problems and contributing to issues management.
- Implementing a risk management approach to support regulatory decisions.
- Dealing with complex issues and managing stakeholders.
- Providing 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.
- Contribute to the development and revision of technical and administrative procedures and documentation within the Branch.
- Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.
About you
- Experience in sequence alignment and antigen/protein modelling in the context of in vitro diagnostic and Medical Device technology
- 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.
- Technical expertise and experience relevant to the use, assessment, manufacture, design, testing and monitoring of Medical Devices.
- Proven ability to produce work requiring little or no revision before finalisation.
- Maintains a flexible attitude, understanding that priorities may change without notice and able to focus on new priorities in accordance with the strategic direction.
Mandatory Qualifications:
- Relevant higher education qualification in health or science related field of studies or biomedical engineering.
Please ensure you meet the requirements for this role before applying for the position. For any questions or further information, please contact Emma at *************@mcarthur.com.au.
