Regulatory Affairs 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 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 Regulatory Affairs Specialist, a purpose driven, high attention to detail individual, with the confidence to support market entry and business growth.  This role ensures that regulatory strategies are effectively implemented across all stages of the product lifecycle — from development through market introduction and post-market surveillance — to enable timely global market access and ongoing compliance.

Key to this role is an ability to work cross-functionally, being
hands-on to complete the primary deliverables of supporting the development, registration, and maintenance of EMVision's medical devices in accordance with applicable regulatory requirements in the European Union (EU), Australia, the United States and elsewhere.

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

• 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, such as during pre-submission information requests, 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 skills, qualities, and experience are as follows:

• Bachelor's degree in a scientific, engineering or health-related discipline.
• Medical device regulatory requirements, as in EU, Australia and United States.
• Global regulatory frameworks and requirements (including EU, Australia and USA).
• Market clearance application preparation (510(k), De Novo and conformity assessment submissions).
• Regulatory reporting mechanisms including field safety actions and change notifications.
• High level of integrity and commitment to compliance.
• Strong written and verbal communication.
• Well organised and high attention to detail.
• Collaborative and solution oriented.

Desirable attributes include:

• Higher level degree (Masters or Doctorate).
• Medical device development, particularly those with electro-mechanical systems, that incorporate software, intended for diagnostic purposes and/or emit radiation.
• Liaising with regulatory authorities and Notified Bodies.
• Clinical evidence requirements for regulatory clearance and/or reimbursement.
• Ability to interpret and apply complex regulatory requirements to practical business situations.
• 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