About Us Resonance Health Ltd is an ASX listed Medical Technology and Services Company. We provide a range of medical services including radiology-image analysis services, specialist services to pharmaceutical and therapeutic companies for their clinical trials, and image data analysis for the diagnosis of disease and management of patients. About You We are seeking an experienced QA & RA Manager to lead the Quality Assurance and Regulatory Affairs function within our growing Software as a Medical Device business. Reporting to senior leadership, this role is responsible for maintaining and continuously improving the company’s Quality Management System (QMS), ensuring compliance with global medical device regulations, and supporting the compliant design, development and release of medical device software products. You will work across the SaMD business to drive a culture of quality, compliance and continuous improvement. Key Responsibilities Lead the company’s Quality Assurance and Regulatory Affairs activities for Software as a Medical Device (SaMD) products. Maintain and improve the Quality Management System (QMS) in line with FDA, EU MDR, ISO 13485 and other applicable standards. Support design and development documentation, including requirements, risk management, verification, validation and release records. Lead and manage regulatory approval processes, including preparation, review and coordination of submission documentation. Develop and maintain SOPs, quality processes and regulatory documentation. Manage regulatory submissions, approvals, reporting obligations and post-market surveillance activities. Review and approve quality, design, development, documentation and product release records. Conduct internal audits and coordinate external audits, including CAPA activities. Support product teams to ensure compliance throughout the product lifecycle. Monitor regulatory and standards changes implement compliance updates as required. Lead management reviews and quality/regulatory reporting. Perform the roles of Management Representative, PPRC and Privacy Officer. About You You are a proactive and detail-oriented quality and regulatory professional with experience in medical device compliance and regulatory submissions. Experience with SaMD is desirable but not essential. You will also bring experience in quality systems, design and development documentation, audit and risk management. Your knowledge and skills in the preparation and submission of regulatory applications to the EUMDR and FDA is important. This experience will be backed by strong problem-solving skills, sound judgement and the ability to balance compliance requirements within a fast-paced technology environment. Skills & Experience Essential Bachelor’s degree in Engineering, Science or a related discipline. Experience in a medical device or SaMD environment. Experience supporting or managing regulatory submissions and approval processes. Knowledge of ISO 13485, ISO 9001, EU MDR, FDA QSR, GMP and GCP requirements. Experience with design and development documentation. Understanding of risk management, risk mitigation and risk controls. Experience conducting internal and external audits. Excellent English language written and verbal communication skills. Strong organisational and stakeholder management skills. What we offer you: A permanent position in a growing company with an exciting vision. A friendly and happy team environment, working with talented and smart people. Broad flexible working arrangements including a 9 Day Fortnight (for full time employees) to enable you to balance collaboration with your other life commitments. A friendly and happy team environment , working with talented and smart people. Head office overlooking a park in a great location with parking , great public transport, and end of trip facilities. A wide range of yummy snacks provided in the office to keep you fuelled up! Market competitive remuneration.
