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

Reporting Relationships:
• 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

Related Experience:
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:
1. Desirable:
• Proactive
• Detail-orientated
• Patient, hardworking
• Good comprehension & writing skill of English
• Expertise in MS Office (Word, Excel)
2. Preferable:
• Strong communication skills
• Problem solving skill

General Requirements:
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

Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Nộp đơn dưới đây

Logo Công ty TNHH Draeger Việt Nam Công ty TNHH Draeger Việt Nam
41-43 Nguyễn Cơ Thạch - Phường An Lợi Đông - Quận 2 - TP Hồ Chí Minh.

Ngày đăng tuyển

Nơi làm việc
Hà Nội

Cấp bậc
Nhân viên

Ngành nghề
Tư vấn pháp lýKhác

Kỹ năng

Ngôn ngữ trình bày hồ sơ
Tiếng Việt

Trình độ học vấn
Cao đẳng

Kinh nghiệm làm việc
1 năm

Ứng viên
Nam nữ
Quality Regulatory Affairs Assistant
Công ty TNHH Draeger Việt Nam
Nộp đơn

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