Regulatory Affairs Specialist

Overview EMVision Medical Devices Ltd (ASX:EMV) is a publicly listed company focused on reducing the global burden of stroke and traumatic brain injury. Our first commercial product, the emu™ (for in-hospital) brain scanner, is currently undergoing an international pivotal trial at leading centres including Mayo Clinic, UCLA, UTHealth and Mt Sinai. The Second product, the First Responder (for pre-hospital), follows closely behind. We are transitioning from a largely R&D focus to commercialisation and preparing for market entry with a pilot production line in Macquarie Park, Sydney. EMVision has been awarded the top innovator in healthcare for the AFR 2023 Most Innovative Companies list and is creating genuine world‑first Australian‑developed neurodiagnostic devices that can be deployed at the scene wherever the patient is located. Key Responsibilities Contribute to the development and execution of regulatory strategies for new and existing medical devices across key markets (EU, Australia, US), including market clearance and reimbursement qualification. Interpret and apply relevant medical device regulations, standards, and guidance documents (e.g., EU MDR 2017/745, Australian Therapeutic Goods (Medical Devices) Regulations, 21 CFR Chapter I, Subchapter H). Monitor evolving global regulatory requirements and assess impact on company products and processes. Prepare and compile regulatory submissions for global regulatory jurisdictions (including technical files, 510k and De Novo). Support preparation of labelling, instructions for use (IFU), unique device identification (UDI) and promotional materials to ensure compliance with regional regulatory requirements. Liaise with global regulatory authorities and notified bodies as necessary during pre‑submissions, device marketing applications, regulatory market actions, inquiries and deficiency responses. Provide regulatory input during product development to ensure compliance with regulatory requirements, particularly with respect to regulatory strategy, applicable standards and guidelines, technical documentation contents and risk management requirements. Support assessments for regulatory reporting with respect to device deficiencies, field incidents and device/system changes. Ensure continued compliance with regulatory requirements through support of post‑market surveillance process, as well as maintenance of product registrations and technical documentation. Assist with regulatory audits and inspections by competent authorities or notified bodies. Comply with EMVision’s quality management system (QMS) and contribute to its continuous improvement. Essential Qualifications Bachelor’s degree in a scientific, engineering or health‑related discipline. Experience with medical device regulatory requirements in EU, Australia and United States. Knowledge of global regulatory frameworks and requirements (including EU, Australia and USA). Experience preparing market clearance applications (510(k), De Novo, and conformity assessment submissions). Experience with regulatory reporting mechanisms including field safety actions and change notifications. High level of integrity and commitment to compliance. Strong written and verbal communication skills. Well organised and highly attentive to detail. Collaborative and solution‑oriented. Desirable Attributes Higher level degree (Master’s or Doctorate). Experience in medical device development, particularly electro‑mechanical systems that incorporate software, intended for diagnostic purposes and/or emit radiation. Liaising with regulatory authorities and notified bodies. Experience with clinical evidence requirements for regulatory clearance and/or reimbursement. Ability to interpret and apply complex regulatory requirements to practical business situations. Knowledge or interest in stroke, traumatic brain injury or other neurological conditions. Contact Human Resources Manager #J-18808-Ljbffr