Mô tả công việc
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
• Functionally reports to: Senior QRA Specialist
Yêu cầu công việc
Education: College degree, vocational training or comparable business experience, medical/technical background prefered but not complusory
1. Desirable: Minimum 1 years of working experience.
2. Preferable: Experience in registration, or working with authorities, or QA (ISO 9001 or ISO 13485 preferred)
Skills, Special Competencies, or Certifications:
• Patient, hardworking
• Good comprehension & writing skill of English
• Expertise in MS Office (Word, Excel)
• Strong communication skills
• Problem solving skill
All employees are expected to:
- Act as an ambassador of and in accordance with the company’s Guiding Principles.
- Adhere to the company’s Principles of Business and Conduct
- Demonstrate good judgment, and respect the confidentiality of company and personnel information.
- Deal professionally and courteously with all internal and/or external contacts.
- Seek guidance and direction as necessary in the performance of duties.
Phúc lợi công việc
- Competitive salary and bonus
- Social insurance, health insurance, unemployment insurance according to Labor Laws
- Professional, dynamic working environment
Cách thức ứng tuyển
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