Medical Device Reviewer
Vor 5 Tagen
Full time
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The APS 6 Medical Device Reviewer is responsible for co-ordinating reviews and undertaking assessments of submissions in relation to the post-market reviews of medical devices.
The APS 6 Medical Device Investigator is responsible for undertaking analysis, risk assessment, case management and investigation of medical device adverse events, as well as undertaking general or specialist assessment of submissions and technical documentation received.
- 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 expertise in the context 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.
- 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.
- Providing advice, assistance and decision making in relation to regulatory action and administrative law processes.
- Managing record keeping in accordance with the regulatory requirements and whole of- government policy and standards.
- Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.
Australia’s health system is world class, supporting universal and affordable access to high quality medical, pharmaceutical and hospital services, while helping people to stay healthy through health promotion and disease prevention activities.
Page last updated: 31 August 2016
The Department of Health has a diverse set of responsibilities, but throughout there is a common purpose, which is reflected in our Vision statement:
Better health and wellbeing for all Australians, now and for future generations.
We aim to achieve our Vision through strengthening evidence-based policy advice, improving program management, research, regulation and partnerships with other government agencies, consumers and stakeholders.
Source: This is an extract from the company's own website.
Overview
Australia’s health system is world class, supporting universal and affordable access to high quality medical, pharmaceutical and hospital services, while helping people to stay healthy through health promotion and disease prevention activities.
Page last updated: 31 August 2016
The Department of Health has a diverse set of responsibilities, but throughout there is a common purpose, which is reflected in our Vision statement:
Better health and wellbeing for all Australians, now and for future generations.
We aim to achieve our Vision through strengthening evidence-based policy advice, improving program management, research, regulation and partnerships with other government agencies, consumers and stakeholders.
Source: This is an extract from the company's own website.
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