Aps6 Medical Device Reviewer

2 weeks ago


Canberra, ACT, Australia Chandler Macleod Full time

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
- 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.
Please Note - The due date for this submission is **30/04/2024.
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