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 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 9769 or email ****** 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
