Compliance & Risk Manager
Vor 4 Tagen
The Compliance & Risk Manager is responsible for building, maintaining, and optimising 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. Lead the organisation’s enterprise risk management framework, including operational, product, data, regulatory, and financial risk domains. Ensure Risk Register and Risk Treatment Plans remain relevant and up to date. 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 programmes. 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. Our Candidate Requirements The qualifications and experience of our ideal candidate 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. Experience with hardware + software medical devices. Background in engineering, science, quality, or legal fields. Key Attributes The technical skills of our ideal candidate Regulatory compliance & medical device standards Vendor and supplier compliance CAPA, internal audits, quality governance Product lifecycle compliance for hardware + software Incident and breach management 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 #J-18808-Ljbffr
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