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Thao Dang

Quality System - Regulatory Affair Executive

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Hai Bà Trưng district, Hanoi, Vietnam

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Timeline
About me
Regulatory Affairs Specialist at ANDAMAN MEDICAL VIETNAM CO., LTD
Education
- Hanoi University of Pharmacy
  2014 - 2019
  Bachelor's degree Quality Assurance Good!
  5 years studying and researching at Hanoi University of Pharmacy has given me a solid knowledge base in the field of pharmaceuticals in particular and health care in general. This gives me the opportunity to improve the health and quality of life for millions.In addition, I developed skills in teamwork, problem solving and task management. This helps me get the job done professionally and efficiently.
- NATIONAL INSTITUTE FOR FOOD CONTROL
  2018 - 2019
  Postgraduate Toxicology & Allergens Excellent
  * Excellent completion of graduation thesis "Quantitative study of some toxins Pyrrolizidine alkaloids inherbs by LC-MS/MS method." with a score 9,1.* Assist to take food samples from market or production facilities to serve the quality and food safety testing.
Experience
- Terumo Medical Corporation
  Aug 2019 - May 2021
  Quality System - Regulatory Affair Executive
  - Preparation and Submission for Free Sale Certificate, New Registration, ChangeNotification, ext...- Update and maintain regulatory database.- Follow-up with the Authority on submitted application until approval process- Carry out appropriate implementation and improve of quality system.- Be in charge of Document Control
- Andaman Medical
  May 2021 - now
  Regulatory Affairs Specialist
  - Consultant on Medical Device Management such as Classification, Registration,Importation, Trading, ext... Advise customers to have most suitable registrationstrategy.- Manage and coordinate multiple registration project.- Preparation of submissions to authorities for new products and variations toexisting products across all risk classification.- Manage regulatory approval/ license and certificate maintenance to ensurecomply with regulation in Vietnam.- Monitor, update and timely reporting on new/changes/upcoming change ofregulation and assess its impact on products.- Build professional working relationship and constantly follow-up with authorities.- Handling post-marketing activities with authority in Vietnam such as AEs, FSCAs,recall and others.- Support distributor in importing or tendering. Show less
Licenses & Certifications
- GDPMD
  MEDIVICE CERTIFICATION
  Apr 2022
- Awareness and Internal Auditor of ISO 13485:2016
  BSI
  Jul 2024