Research, Development and Regulatory Affairs Manager - Medical Devices

About RaaS TechRaaS Tech is building an AI-powered healthcare robotics platform that brings together robotics, cloud infrastructure, IoT connectivity and artificial intelligence to support remote healthcare, telehealth and connected medical devices. We work closely with international robotics manufacturers and technology partners to bring next-generation healthcare technology to the Australian and global market. As we grow, we're looking for people who want to help shape that journey from the ground up. About the RoleWe are seeking an experienced Research, Development & Regulatory Affairs Manager – Medical Devices to lead the research, development, regulatory approval and compliance activities associated with our next generation of connected healthcare technologies. The role will work across medical devices, healthcare robotics, remote patient monitoring, connected diagnostic devices, software and AI-enabled healthcare technologies, helping take products from initial concept and technical evaluation through validation, regulatory approval and commercial deployment. A major focus of the position will be navigating the Australian Therapeutic Goods Administration (TGA) regulatory framework and establishing the technical documentation, quality systems, risk management and compliance processes required to bring medical-device technologies to market. Key ResponsibilitiesLead research and development activities for new healthcare technologies, medical devices and connected health products.Assess new medical devices, sensors, diagnostic equipment and healthcare technologies for integration into the company's technology platform.Develop product requirements, technical specifications and R&D documentation.Coordinate prototype development, testing, verification and validation.Manage the Australian TGA medical-device regulatory pathway, including product classification and applicable conformity assessment requirements.Prepare and coordinate documentation supporting ARTG inclusion and other applicable regulatory submissions.Review manufacturer documentation, technical files, certificates, test reports and declarations of conformity.Liaise with overseas medical-device manufacturers to obtain regulatory and technical documentation required for the Australian market.Maintain regulatory documentation and evidence throughout the product lifecycle.Develop and maintain compliance processes aligned with relevant medical-device standards and regulatory requirements.Support implementation and maintenance of an appropriate Quality Management System (QMS).Work with standards and frameworks including ISO 13485, ISO 14971, IEC 60601, IEC 62304 and IEC 62366, where applicable to the particular product.Coordinate electrical safety, EMC, wireless/communications and other applicable product testing and certification requirements.Undertake and maintain product risk assessments and risk-management documentation.Support cybersecurity, software, cloud and connected-device compliance requirements.Maintain design-control documentation, technical files, product records and change-control processes.Establish procedures for post-market monitoring, incident reporting, complaints, corrective actions and product improvements.Monitor changes to Australian and international medical-device regulations and standards.Support future international regulatory strategies including FDA, EU MDR/CE, Health Canada, UK MHRA and New Zealand Medsafe, as required.Work closely with engineering, software, robotics, healthcare, commercial and executive teams to ensure products are technically viable, compliant and commercially scalable.Qualifications & ExperienceIdeally, the successful candidate will have qualifications or significant experience in one or more of the following: Biomedical Engineering, Medical Engineering, Electronics Engineering, Mechatronics, Software Engineering, Regulatory Affairs, Quality Assurance, Medical Device Development or a related discipline. Experience with TGA-regulated medical devices is highly desirable. The ideal candidate will have demonstrated knowledge of: Australian medical-device regulatory requirementsTGA and ARTG processesMedical-device classificationQuality Management SystemsISO 13485ISO 14971 risk managementVerification and validationTechnical documentationProduct testing and certificationSoftware and connected medical devicesRegulatory submissionsSupplier/manufacturer compliancePost-market surveillanceExperience dealing with international manufacturers, particularly OEM/ODM medical-device manufacturers, would be highly regarded. Key AttributesWe are looking for someone who can operate across both innovation and regulation. The successful candidate should be: Technically strong and commercially awareHighly organised and documentation focusedComfortable working with emerging technologiesCapable of managing multiple regulatory and development workstreamsAble to communicate effectively with engineers, manufacturers, regulators and executivesDetail oriented with a strong understanding of risk and complianceProactive in identifying regulatory or technical issues before they become commercial problemsComfortable operating within a fast-growing technology companyPosition ObjectiveThe objective of this role is to establish a robust pathway from: Research → Product Selection → Development → Integration → Testing → Validation → TGA/Regulatory Approval → Commercial Deployment → Post-Market Compliance The position will play a critical role in ensuring that innovative healthcare technologies can be introduced to market safely, efficiently and in accordance with Australian and international medical-device requirements.