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 *****, ISO *****, 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 *****).
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 *****.
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 *****, ISO *****, 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
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