About VitalTrace
VitalTrace Pty Ltd is a multi-award-winning, VC-funded Australian-based Med-tech start-up company aiming to improve outcomes for mothers and children during the childbirth process. We are doing this by developing novel cutting-edge biosensor technologies for fetal monitoring during childbirth. We believe that mothers and babies deserve the highest standard of care, and that childbirth monitoring should be accurate and allow clinicians to make informed and timely decisions. We have a vibrant culture with a diverse, high-performing multidisciplinary team of clinicians, researchers, engineers, chemists, software developers, and data scientists all working towards the same goal.
Responsibilities
Regulatory Submissions:
Prepare, compile, and maintain high-quality regulatory dossiers and technical files for global submissions including FDA (510(k), PMA), TGA, and CE Marking through EU Notified Bodies.
Agencies Liaison:
Serve as the direct point of contact with regulatory agencies, notified bodies and country representatives. Manage communication and ensure timely responses to inquiries, deficiency letters, and requests for additional information.
Project Team Representation:
Act as the regulatory liaison on cross-functional project teams, including liaising with consultants as appropriate, from concept through to commercialisation and post-market activities, ensuring regulatory requirements are integrated into development plans.
Quality System Compliance:
Support the teams to maintain regulatory compliance across all areas of the business, including general quality management, design control, risk management, and post-market surveillance.
Regulatory Intelligence:
Conduct ongoing regulatory intelligence to monitor changes in global regulations, standards, and guidance documents. Communicate updates and provide strategic recommendations to relevant internal stakeholders.
Clinical Support:
Collaborate with the clinical affairs team to ensure that clinical trial designs align with regulatory expectations. Provide regulatory input during the planning, conduct, and reporting of clinical studies.
Requirements
Skills and Experience
* Minimum of 2–4 years of regulatory affairs experience in the medical device industry.
* Previous interactions with regulatory authorities (e.g., FDA, TGA, EU NB).
* Solid understanding of medical device regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and other relevant global requirements.
* Experience preparing regulatory submissions for Class II/III medical devices.
* Experience with clinical trial regulatory requirements (e.g., GCP, ISO
* Strong analytical, organisational, and problem-solving skills.
* Excellent written and verbal communication skills.
* Ability to manage multiple projects and priorities in a fast-paced environment.
* Detail-oriented with a high degree of accuracy.
Qualifications
* Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field (Master's degree preferred).
* Working rights in Australia