Clinical Affairs Associate

• 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 and traumatic brain injury care.

Join EMVision and be a part of a company developing and commercialising innovative world-class portable brain scanner products to transform the timely diagnosis and treatment of neurological emergencies, such as stroke. EMVision's products have the potential to positively impact the lives of millions of patients globally. Having been awarded the top innovator in healthcare for the AFR 2023 Most Innovative Companies list, EMVision is creating genuine 'world first' Australian developed and produced neurodiagnostic devices that can be deployed at the scene, wherever the patient is located.

EMVision Medical Devices Ltd (ASX:EMV) is a publicly listed company with ambitions to help reduce the global burden of stroke and traumatic brain injury.  Our first commercial product, the emu (for in-hospital) brain scanner is presently undergoing an international pivotal trial at leading centres such as Mayo Clinic, UCLA, UTHealth and Mt Sinai, among others, to support regulatory clearance. Our second product, the First Responder (for pre-hospital) is following closely behind.

We are currently transitioning from a largely R&D focus to a focus on commercialisation and preparing for market entry. We are pursuing a United States first approach, with global expansion ambitions. We have established a pilot production line in Macquarie Park, Sydney.

With this transition underway, we are seeking an experienced Clinical Affairs Associate, to support the planning, execution, analysis and reporting of clinical activities across the product lifecycle of EMVision medical devices – ranging from pre-market clinical investigations, through clinical evaluation, literature and post-market surveillance including post-market clinical follow-up.

The role is central to EMVision medical device development and regulatory compliance and thus ensures conduct of these activities in accordance with applicable standards (ISO 14155, ISO 13485), regulations (in Australia, Europe and United States) ethical guidelines, and company policies.

Key to this role is an ability to work cross-functionally, being hands-on to complete the deliverables of generating, analysing, and maintaining clinical evidence to support regulatory submissions, ongoing device safety monitoring, and market access objectives.  This role will be responsible for providing clinical expertise and guidance in cross-functional project teams.

Joining a small and dedicated team, and reporting through to the Head of Regulatory Affairs, the key responsibilities of this role include:

• Support the design, initiation, conduct, analysis and reporting of clinical investigations in accordance with ISO 14155, GCP, applicable regulations and company procedures.
• Prepare and maintain study documentation (e.g. ethics applications, protocols, informed consent forms, investigator brochures, CRFs, monitoring plans, reports).
• Conduct site visits including at initiation, regular monitoring and closure (requiring occasional interstate travel).
• Liaise with investigational site research staff as necessary
• Support the analysis of clinical data including that from clinical investigations, literature review and post-market surveillance
• Conduct Clinical Evaluations in accordance with applicable regulations (Australia and EU) and guidance (e.g. MDCG), including planning, literature review, data collation, analysis and reporting
• Support the development and implementation of PMCF Plans and Reports, ensuring continuous assessment of device safety and performance in real-world use.
• Support the analysis of post-market clinical data sources, including published literature, complaint data, and vigilance reports.
• Collaborate with cross-functional teams to provide clinical input, such as to product development (e.g. risk management) and regulatory (e.g. marketing applications).
• Support the preparation of presentations, white papers, and publications based on clinical data.
• Comply with EMVision's quality management system (QMS) and contribute to its continuous improvement.

Essential skills, qualities, and experience are as follows:

• Bachelor's degree in a scientific, engineering or health-related discipline.
• Medical writing.
• Systematic literature review.
• Data management and analysis techniques.
• Strong written and verbal communication.
• Well organised and high attention to detail.
• Analytically minded and problem-solving oriented.

Desirable attributes include:

• Higher level degree (Masters or Doctorate).
• Good Clinical Practices (GCP).
• Conduct of clinical research (e.g. CRA or CRC experience).
• Medical devices, particularly those with electro-mechanical systems, that incorporate software and/or are intended for diagnostic purposes.
• With Quality System requirements, as per ISO 13485.
• With Regulatory requirements, as in EU, Australia and United States.
• With ethical requirements of research involving human participants.
• Stroke, traumatic brain injury or other neurological conditions.

For further information about this opportunity, or to submit your application, please contact:

Kirste Courtney, Human Resources Manager