Company Description Voyager Imaging is Australia’s pioneering medical imaging software company, supporting radiology service providers for more than 30 years. The organization delivers specialized solutions including Picture Archiving and Communication Systems (PACS), Radiology Information Systems (RIS), and teleradiology platforms to streamline clinical workflows.

Voyager

Imaging also offers clinical and patient portals that improve access to imaging information and enhance communication between healthcare professionals and patients. Integration services and dedicated support help clients connect their systems securely and maintain reliable performance across their imaging environment.

Role Description The Quality and Regulatory Manager is a full time (or part time depending on experience), on-site/offiste role based in Melbourne, VIC (interstate candidates will be considered). This role is responsible for developing, implementing, and maintaining the company’s quality management framework to ensure medical imaging software and services meet internal standards and external regulatory requirements. Day-to-day tasks include monitoring compliance with relevant regulations and standards, conducting and/or supervising internal audits, reviewing and updating quality and regulatory documentation, and overseeing corrective and preventive actions.

The role collaborates closely with product, engineering, and support teams to embed quality practices in development, testing, deployment, and customer support processes.



The Quality and Regulatory Manager also prepares for regulatory inspections, supports certification activities, and provides training and guidance to team members on quality and compliance topics.

Qualifications

- Demonstrated skills in Quality Management, including establishing, maintaining, and improving quality management systems in a technology or healthcare environment.
- Experience with Quality Assurance and Quality Control practices to ensure software and services consistently meet defined standards and customer expectations.
- Strong knowledge of Regulatory Compliance and Regulatory Requirements relevant to medical software, health information systems, or medical devices.
- Experienced in ISO13485, the Australian Medical Device Regulations, the European Medical Devices Directive (MDD) 93/42/EEC & 2007/47/EC as well as EU MDR 2017/745, the US Code of Federal Regulations and others.
- Ability to interpret technical and regulatory documentation and translate requirements into clear processes and policies.
- Relevant tertiary qualification in engineering, science, quality management, healthcare, or a related discipline.
- Excellent analytical, problem-solving, and organizational skills, with attention to detail and a structured approach to documentation.
- Strong communication and stakeholder management skills, with the ability to collaborate effectively across multidisciplinary teams.

Please send resume to [email protected]

📌 Quality and Regulatory Manager (Melbourne)
🏢 VOYAGER IMAGING
📍 Melbourne