Regulatory Affair

1 day ago


Hanoi, Vietnam Công ty Cổ phần Medcomtech Full time

**Primary Function**:
A Regulatory Specialist who, working with little or no supervision, applies scientific knowledge, experience and ingenuity to register new product, renew licenses, file change notification, variation at Ministry of Health.

**Core Job Responsibilities**
- Follow up the Decision/ Regulation/ Acts/ Circulation issued by competent authorities.
- Register new product, renew licenses, file change notification, variation as MoH request.
- Follow up the validity of licenses of Medcomtech’s products.
- Keep contact with manufacturers to get documentations for registration.
- Update database in regulatory system.
- Support marketing team related to advertising license and compliance of advertising material.
- Support commercial team related to tender.
- Comply with PV policies, procedures on quality system & requirements for related responsibilities.
- Perform other activities assigned and/or instructed by direct supervisor.

**Benefit**
- Working days from Monday to Friday
- Salary about 15-16 million VND per month
- Attractive career opportunities and rewarding job experience
- Training and Development.
- Professional office environment.

**PREFERRED REQUIREMENTS**
- Having 2 year experience in relevant position, registration of medical devices product.
- Have knowledge about register new product, renew licenses and relevant laws.
- Having network with Vietnam MOH will be advantageous
- Meticulous and results-oriented
- Must be able to work independently with minimum supervision
- Verbal and written English communications skills.
- University degree in Medicine, Pharmacy, or Natural science - Chemistry, Biology

**Salary**: 12,000,000₫ - 18,000,000₫ per month


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