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Aps6 Medical Device Reviewer
2 weeks ago
Location
- Canberra, Australian Capital Territory
Category
- Executive
Salary
- $ AUD - $ AUD Hourly
-
Posted
- 24Apr2024
Work type
- Full Time
Contact
- Jess Kaur
Reference
- BH160022
- Our 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 multicomponent 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
- 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.
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