Regulatory Affairs Specialist - Contractor 1 Year (Core Diagnostics - Based in Hanoi)

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

Education: Medical Doctor, Pharmacist preferable.
Background and Experiences:
Previous working experience in medical device company and dealing with Vietnam Ministry of Health is an advantage
English proficiency.
Knowledge of regulations and standards affecting IVDs and Biologics

Competitive salary package

Training

Cập nhật gần nhất lúc: 2021-08-25 05:10:27