Our client is responsible for complex monitoring, analysis, investigation and review activities for post market regulatory programs for medical devices, including key COVID-19 reviews of facemasks, and implementation of review outcomes. In addition, the section is responsible for undertaking the post-market reforms program of work to implement recommendations and commitments made in The Action Plan for Medical Devices.
The Medical Device Assessor is responsible for co-ordinating and undertaking assessments of submissions in relation to medical device post-market reviews, applications for inclusion of Class I medical devices, applications for consent to supply non-compliant medical devices, and monitoring lapses in conformity assessment certification.
1. Undertaking assessment of the technical documentation and data, preparing a clear statement of reasons based on the assessment findings and knowledge of the regulations, and exercising delegation where appropriate.
2. Undertaking under limited direction, risk assessments of applications for consent to supply non-compliant medical devices and lapses in conformity assessment certification.
3. Managing record keeping in accordance with the regulatory requirements and whole of-government policy and standards.
4. Providing inputs and advice to the policy development and business improvement related to medical devices when required and where appropriate.
5. Contribute to the development and revision of technical and administrative procedures and documentation within the Branch.
6. Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.
The following experience would be desirable but not essential
Candidates will need to have exceptional attention to detail, well developed analytical skills, and have a ‘can-do’ approach to achieving outcomes and meeting deadlines.
If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
0403 200 666
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