Mô tả công việc
• Study clinical & legal document
• Gather, evaluate, organize, manage & collate information in a variety format
• Be responsible for compliance & submission of drug & medical device registration dossiers, recalls & adverse incidents reporting to the MOH. Review and update information, labels and other documentation as required for regulatory compliance, liaise with VARANS, Drug Admin Department & other relevant Government agencies when required
• Maintain and track the registration status of all marketed products
• Provide regulatory inputs and support for marketing plans, product registration and variations to the marketed products
• Compile and maintain regulatory documentation database on server
• Maintain strong working relationships and positively inform regional personnel and the distributor
• Other tasks are assigned by Line manager.
Yêu cầu công việc
• Bachelor Degree
• At least 1-2 year experience in relevant field. Experience and knowledge of medical devices industry will be an advantage.
• Good skill for MS Office (Word, Excel and PowerPoint)
• Good command of spoken and written English. It is a must.
• Ability to work independently as well as in team
• Possess keen interest in operations and regulatory work
• Expertise for the Vietnam regulatory issues preferred
• Pleasant, positive, meticulous, responsible and proactive in work, independent worker who is able to multi-task
• Able to handle administrative duties with good document organization skills
• Excellent in time managing skills
• Open-minded, honest, careful, and hard-working.
Quyền lợi được hưởng
- In accordance with company policy
Thông tin liên hệ
- Người liên hệ: transmedic co.,ltd
- Địa chỉ: