Again today another role posted on seek, Clinical Evaluation...

Again today another role posted on seek, Clinical Evaluation Specialist. This time Christian Wight, Head of Regulatory Affairs at EMV promoting on LinkedIn. Things are ramping up in the FDA space and approach at EMV it seems.

Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

https://www.iso.org/iso-13485-medical-devices.html#:~:text=Who%20is%20ISO%2013485%20for,them%20with%20their%20auditing%20processes.

https://www.seek.com.au/job/74443878?ref=search-standalone&type=standard#sol=efc60fbb077f579bc3f49412938c7

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We are looking for a Clinical Evaluation Specialist to be an integral part of the EMV regulatory environment, focusing specifically on the provision of clinical evaluation, including but not limited to collection, appraisal, and analysis of clinical data of EMV’s medical devices to demonstrate conformity to ISO13485.

There is defined responsibility in relation to the development of clinical and scientific documents in accordance with EMV procedures and regulatory requirements. This includes, research, assistance in the execution of clinical trials, conducting literature reviews, writing clinical evaluation reports and plans, analysis of product complaints and trends, collecting and analysing feedback from various sources.

The incumbent will provide critical expertise and guidance for cross-functional teams from the planning to execution phases to ensure the clinical documents meet the highest standards and provide the necessary data to support marketing applications.

Working as part of a team, and reporting through to the Head of Regulatory Affairs, the key responsibilities of this role include:

Primary person for the collection of clinical data, development and generation of clinical evaluation plans and reports.

Expert in relation to the clinical regulations and guidance to help EMV develop appropriate strategies and to streamline the final execution.

Lead training as required, for cross-functional teams to help ensure consistency in the execution of clinical documents across EMV.

Participate in the post market clinical planning, development, and execution.

Specifically contribute to the literature research, review and the identification and analysis of clinical data.

Perform the completion of comprehensive systematic, documented literature reviews using various resources to support the clinical evaluation, post-market clinical follow-up, and protocol development.

Collate and analyse clinical trial data generated by EMVision sponsored clinical trials.

Assist in the planning, management and execution of EMVision sponsored clinical trials.

Author publications of EMVision sponsored clinical trials in peer-reviewed journals.

Analyse clinical evidence to evaluate the safety and performance of the device under evaluation.

Provide strong and diligent medical and technical writing skills.

Demonstrate sound knowledge and understanding of proposed and current global regulations and the ability to relay the impact of such regulations internally.

Ensure documents are produced in accordance with procedures, as well as internal and external guidelines. Compile documentation for clinical trials and regulatory submissions.

Detailed knowledge of clinical research and regulatory requirements.9a80f173a23