Clinical Evaluation Specialist

• Winner of the AFR 2023 Most Innovative Companies Award in Healthcare.
• Medical device industry, based in Macquarie Park.
• Opportunity to join a progressive and well-funded start-up Company.
• Work on world first products set to transform stroke care.

Join EMVision and be a part of a company developing and commercialising game changing portable brain scanner products to transform stroke care and in doing so positively impact the lives of millions globally.

Having just been named the top innovator in healthcare for the AFR 2023 Most Innovative Companies, EMVision is developing point-of-care brain scanners, for rapid stroke diagnosis and monitoring, wherever the patient is located. 

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.

If you have the following skills, qualities, and experience, we would like to hear from you:

• Life Sciences degree (BSc, MSc or PhD) with the ability to read and then process/analyse scientific literature.
• Medical writing experience.
• Understanding of clinical experience data such as clinical outcomes and complaints and sales numbers.
• Experience in medical devices, post-market surveillance activities or clinical data management.
• Experience in European Medical Device Regulations, Australian Therapeutic Goods (Medical Devices) Regulations and USA 21 CFR Subchapter H Regulations. 
• Direct experience working on Clinical Evaluations within the medical device industry.
• Medical writing certification is desirable.
• GCP trained desirable.
• Experience in stroke related research desirable.
• Exceptional communication skills, both verbal and written.
• Demonstrated ability to analyse and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Well organised and structured; high attention to detail.