Quality and Regulatory Analyst

Role Overview

• Coordinate tasks related to the Quality Management System (QMS), ensuring compliance with principal company requirements, Good Wholesaling Practice (GWP), and applicable regulatory frameworks
• Assist with the quality operations of our 3PL warehouse, ensuring compliance with local regulations and corporate standards
• Assist in developing and executing internal and external audit procedures to ensure continual compliance and quality improvement
• Manage all aspects of pharmacovigilance and device vigilance activities for AMSL and NZMS, ensuring timely reporting and compliance
• Review advertising and promotional materials to ensure alignment with local advertising codes and regulatory requirements
• Support the preparation and submission of regulatory documentation to obtain and maintain product registrations in Australia and New Zealand
• Conduct reviews of relevant legislation and regulatory updates and manage product recalls in compliance with applicable codes/standards
• Support onboarding and training of new employees in QMS procedures and related areas
• Investigate and document quality issues and non-conformances, working cross-functionally to implement corrective and preventive actions

Requirements

• Proven experience in developing and implementing ISO 9001:2015-compliant QMS
• Knowledge of medical device registration processes with both Medsafe (NZ) and the TGA (Australia)
• High attention to detail and strong analytical thinking
• Excellent organisational and time management skills
• Strong written and verbal communication
• Proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint, Word)

Benefits

• Flexible work arrangements