Regulatory Affairs Officer - Temp 6 months - Ha Noi

• Knowledge of regulations and standards affecting IVDs and Biologics
• English proficiency
• Previous working experience in medical device company and dealing with Vietnam Ministry of Health is an advantage

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