Compliance & Risk Manager
Location: Melbourne, Victoria, Australia
Salary: A$250,000.00 - A$300,000.00
About the Role
The Compliance & Risk Manager is responsible for building, maintaining, and optimizing the organisation's compliance, regulatory, and risk frameworks as the company scales. This role ensures the business meets all applicable regulatory obligations across operations, including software/hardware products, and specifically Medical Device requirements (e.g., ISO 13485, ISO 14971, TGA, FDA, etc). The position is both strategic and hands‑on, suited to a rapidly growing environment where systems, processes, and governance structures are being built or formalised.
Role Responsibilities
Regulatory Compliance (General Business and Medical Devices)
* Maintain compliance with all relevant medical device regulations (e.g., TGA, FDA, EU MDR, ISO 13485).
* Oversee product compliance activities, including documentation, change control, and QMS processes.
* Manage post‑market surveillance, reporting requirements, and regulatory submissions.
* Partner with product, engineering, and manufacturing teams to ensure new and updated products meet regulatory requirements.
Risk Management
* Lead the organisation's enterprise risk management framework, including operational, product, data, regulatory, and financial risk domains.
* Ensure the Risk Register and Risk Treatment Plans remain current.
* Facilitate company‑wide risk assessments and support teams in implementing mitigations.
* Ensure medical device risk management files comply with all required standards including ISO 14971.
Quality & Governance
* Maintain and improve the Quality Management System (QMS) including SOPs, work instructions, templates, and compliance tools.
* Conduct internal audits, coordinate external audits, and manage/guide corrective and preventive actions as required.
* Oversee supplier audits and vendor compliance.
* Ensure document control processes meet regulatory standards.
Policy & Process Leadership
* Collaborate across departments to embed compliance into product development lifecycle, manufacturing, customer operations, and commercial processes.
* Develop and implement compliance policies, standards, and training programs.
* Educate and influence stakeholders to build a culture of compliance and risk awareness.
* Provide compliance and risk reporting to the Executive team and Board.
* Support incident management, breach reporting, and crisis response planning.
Candidate Requirements
* 7–10+ years' experience in compliance, risk management, or regulatory affairs.
* Demonstrated experience with Medical Device regulatory frameworks (ISO 13485, ISO 14971, MDR, TGA, FDA 21 CFR 820).
* Experience in a scale‑up or high‑growth technology/manufacturing environment.
* Strong understanding of enterprise risk management principles.
* Proven experience managing audits and maintaining QMS compliance.
* Excellent documentation, analytical, and communication skills.
Desirable Experience
* Experience with hardware + software medical devices.
* Risk management certification (e.g., ISO 31000, CRM, CERA).
* Background in engineering, science, quality, or legal fields.
Key Attributes
* Regulatory compliance & medical device standards.
* Risk assessment & mitigation.
* ISO framework management.
* Vendor and supplier compliance.
* CAPA, internal audits, quality governance.
* Product lifecycle compliance for hardware + software.
* Incident and breach management.
* Documentation excellence.
Behavioural Competencies
* Strong stakeholder engagement.
* Adaptable to ensure balance between business needs and compliance requirements.
* Ability to thrive in ambiguity and build systems from scratch.
* Analytical, structured, and detail‑oriented.
* Strategic thinker with operational execution capability.
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