Quality Regulatory Affairs Assistant

Department: Quality & Regulatory Affairs

Purpose of Function:
Support & perform regulatory & quality tasks as assigned by QRA Specialist in full compliance with local regulations.

Tasks and Responsibilities:
1. Regulatory Affairs/ Product Registration
• Prepare, submit and follow up for product approvals and registrations in full compliance with local regulations while building and maintaining good relation with health authorities
• Work with internal departments to support Drager’s product registration needs such as consolidating Vietnamese Instructions for Use/Quick guides, and making Vietnamese labels
• Work with external stakeholders such as local RA partners engaged in the registration process
• Support in tender requests, customer inquiries for QRA issues; reporting variations, and other reporting to authorities.

2. Intergrated System Management & Quality Affairs
• Support Integrated Management Systems: field actions, corrective action, product recalls if there is, advisory/warning notices, customer complaints, non-conforming products - including manage internal quality systems
• Implement and maintain effective controls for non-conforming product handling, reporting, labelling and disposition
• Support internal & external audits by notified bodies in collaboration with Regional Quality Manager and elimination of findings with appropriate immediate actions, corrective actions and effectiveness checks

3. Occupational Health & Safety, Environmental System
• Maintain and monitor library of regulations, policies, standards, and other quality, occupational HSE system documentation as required, online and offline
• Coordinate related events and trainings, consolidate HSE data, register incident and accident, incident investigations if there is

4. Other assigments by QRA Specialist
• Administrative tasks

Reporting Relationships:
• Functionally reports to: Senior QRA Specialist