This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
We are seeking an experienced Quality, Regulatory and Sustainability Manager to join our team, leading quality, regulatory and ESG functions across our ANZ business. This is an autonomous role and is the primary contact for ANZ, working very closely with our global Quality and Regulatory (QARA) teams in EMEA and the APAC Regional Leadership Team. The Quality, Regulatory and Sustainability Manager is responsible for localising and embedding global quality systems, ensuring compliance with ISO: 13485, ISO:14001, TGA and Medsafe requirements, overseeing regulatory compliance and submission, leading ANZ audits, and championing continuous improvement and sustainability initiatives and strategies aligned with our global QARA and ESG objectives.
Job Responsibility:
Own and continuously improve the ANZ ISO13485 QMS and related quality systems
Lead internal and external audits including local ANZ cross audits and ensure ongoing regulatory compliance
Manage complaints, CAPA, non-conformances, supplier quality and product risk
Act as the primary liaison with TGA, Medsafe and external compliance bodies ensuring compliance with requirements for medical devices, including listing/notification processes, post-market surveillance obligations, field safety notifications, incident reporting, and recalls
Oversee SOPs, document control and training
Lead ISO 14001 compliance and deliver the EcoVadis sustainability assessment
Drive sustainability initiatives and report on ESG performance
Partner with commercial, people, operational and global teams to build capability and embed quality and compliance
Requirements:
A tertiary qualification in Quality, Science, Engineering or similar
5+ years’ experience in quality and regulatory roles within medical devices or regulated industries
Strong knowledge of ISO 13485, ISO 14001, GDP and ANZ regulatory frameworks
Audit leadership experience and exposure to sustainability or ESG initiatives
Excellent communication, judgement, critical thinking and problem-solving skills
Experience with TGA, Medsafe and global QMS/WMS environments will be highly regarded