Compliance & Risk Manager

Compliance & Risk Manager – Build Governance for Next-Generation Technology Full-Time | Melbourne Based | High-Growth Environment The Company A fast-scaling Australian tech organisation is pioneering advanced software and hardware solutions being deployed globally across critical industries, including regulated medical and high-compliance environments. After a significant R&D phase, the business is now in a period of rapid commercial growth — expanding its footprint across domestic and international markets.With innovative technology, smart people and strong backing, the company is building the frameworks, systems and governance that will support it through its next stage of scale. This is a place where you can shape the future, not just maintain it. The Role We are seeking a Compliance & Risk Manager to lead regulatory oversight, risk management, and quality frameworks across the organisation as it grows. You will own the development and optimisation of compliance systems, ensuring the business meets all obligations — particularly in relation to Medical Device regulations including ISO standards and global regulatory bodies.This role blends strategy and execution. Perfect for someone who loves structure, thrives in scale-up environments and wants to build foundations that last. Responsibilities Regulatory Compliance – Medical Device & General Business Maintain compliance with TGA, FDA, EU MDR and relevant standards (ISO 13485) Oversee product compliance, documentation control and QMS processes Lead regulatory submissions, post-market surveillance and reporting Partner with product, manufacturing and engineering to ensure regulatory alignment Risk Management Lead enterprise risk frameworks across product, data, operational & regulatory domains Maintain Risk Registers, treatment plans & drive company-wide risk ownership Support teams with assessments, mitigations & compliance preparedness Ensure medical device risk documentation meets ISO 14971 Quality & Governance Maintain and enhance QMS frameworks, SOPs, policies & templates Conduct internal audits and coordinate external audits Oversee corrective actions, supplier audits and vendor compliance Ensure robust document control and traceability systems Policy, Process & Training Embed compliance across product lifecycle, operations & manufacturing Implement policies, training and scalable governance practices Be a trusted advisor across the organisation, driving a culture of compliance excellence What We Need from You You bring strong regulatory and compliance knowledge, ideally within medical device, hardware, or high-governance tech environments. You love structure, detail and are energised by building frameworks that support growth.You will have: Experience owning compliance frameworks in regulated environments Deep understanding of ISO 13485, ISO 14971, TGA, FDA & global medical device regulations Strong documentation, auditing and QMS capability The ability to work cross-functionally and influence behaviour through strong communication Comfort operating both strategically and hands-on Curiosity, initiative and a continuous improvement mindset If you’re looking for a role where your work truly shapes future success — this is it. Benefits Make your mark building compliance foundations for an emerging global product Work with cutting-edge technology in an exciting growth phase High-autonomy role with meaningful strategic influence Collaborative, supportive team environment Career progression as governance structures mature Apply Now If you love compliance, thrive in growth environments, and want to build frameworks that power innovative technology to scale — we’d love to hear from you. Apply with your CV and a brief cover letter outlining your experience.  Redwolf + Rosch invite and encourage applications from all backgrounds of gender, disability, culture, and race. If you are a person with a disability and require modifications to the recruitment process, please contact the Recruitment Consultant