Quality and Regulatory Analyst
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Job Description
Quality and Regulatory Analyst ensuring compliance with QMS and regulatory requirements in diabetes-related medical devices. Collaborating with teams to maintain high standards in product quality and regulatory practices.
Responsibilities:
- 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
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