AddressOur client is seeking to engage an APS6 Medical Device Reviewer
Location: Canberra, ACT
Contract Length: Start – 03/06/2024, End – 30/05/2025, with option to extend up to 12 months
Eligibility/Security Requirement:Australian Citizenship
Areas of Responsibility
The APS6 Medical Device Reviewer is responsible for coordinating reviews and undertaking assessments of submissions in relation to the post-market reviews of Medical Devices.
Key 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 signals associated with Medical Devices.
- 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.
- 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 on Agency’s website.
- Representing the Agency 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.
If you feel you are a suitable candidate submit your application by hitting “Apply for this job”. Alternatively, you can call Isaac Benjamin on 02 6268 9*** or email **************@chandlermacleod.com for further discussion.
Please Note – The due date for this submission is 30/04/2024.
At Chandler Macleod, we are committed to fostering a diverse workforce where everyone is welcome. We encourage applications from Aboriginal and Torres Strait Islander peoples, women, people living with a disability and the LGBTIQA+ community.
You can read more about our commitment to diversity and inclusion at https://www.chandlermacleod.com/diversity-and-inclusion
