Position Title: Quality & Regulatory Affairs Assistant

Department: Quality & Regulatory Affairs

Functionally reports to: Senior QRA Specialist

Tasks and Responsibilities:

1. Regulatory Affairs/ Product Registration (from 70%)

• 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/letters for QRA issues; reporting variations, and other reporting to authorities.

2. Intergrated System Management & Quality Affairs (15%)

• 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 Head; elimination of findings with appropriate immediate actions, corrective actions and effectiveness checks

3. Occupational Health & Safety, Environmental System (5%)

• 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 (10%)

• Administrative tasks such as payment, dossier filling
• Note: Proportion & priorities of the job can change depends on the needs of work & regulations at a given time.

Position Requirements:

• College degree, vocational training or comparable business experience, medical/technical background prefered but not complusory
• Minimum 1 years of working experience.
• Experience in registration, or working with authorities, or QA  (ISO 9001 or ISO 13485 preferred)
• Proactive
• Detail-orientated
• Patient, hardworking
• Organized
• Good comprehension & writing skill of English
• Expertise in MS Office (Word, Excel)
• 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.

For more the information please contact our consultant:

Ms Phuong

02839154343 ext 113

  phuong.nguyen@firstrecruitment-asia.com

Ms Susan

02839154343 ext 111

  susan.ho@firstrecruitment-asia.com