Address- 6 Month Contract + 12 Month Extension
- Ability to obtain a Baseline Clearance
- Expected September Start Date
Our Client, an established Federal Government Department is seeking an enthusiastic Medical Device Reviewer to be be responsible for co-ordinating review and undertaking assessments of submissions in relation to the post-market reviews of Medical Devices.
Key Duties will include:
- 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 performance or safety signals associated with Medical Devices;
- Coordinating and managing multi-component assessments 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;
- Managing record keeping in accordance with the regulatory requirements and whole of- government policy and standards;
- Providing inputs and advice to the policy development and business improvement related to Medical Devices when required and where appropriate;
- Writing statements for publication on the safety and performance of Medical Devices for publication on the Department's website;
- Representing the Department at education seminars, conferences, and workshops;
- 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.
For a copy of the full job description, including application instructions please get in touch with Recruitment Hive by clicking the Apply Now button. Alternatively, you can reach Alison on (02)6299 1*** to discuss further.
Please note, applications close on the 4th of July at 10:00AM
Job ID AC 9555
