Experience

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  HCLTech Vietnam

  • Vietnam

  • Senior Regulatory Analyst

    • Nov 2021 - Present
    • Vietnam

    Execute MDR gap assessment for client's productsExecute standards gap assessment to ensure product complying to the latest version of standards (usability, electrical, risk management...)Remediate the gaps to ensure client's products meet standards requirements and regulatoryParticipate in projects that clients are leading medical device manufacturers

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  VT healthcare

  • Ho Chi Minh City, Vietnam

  • Quality Assurance and Regulatory Specialist

    • Nov 2020 - Nov 2021
    • Ho Chi Minh City, Vietnam

    Execute MDR gap assessment for client's productsExecute standards gap assessment to ensure product complying to the latest version of standards (usability, electrical, risk management...)Remediate the gaps to ensure client's products meet standards requirements and regulatoryParticipate in 2 projects that clients are leading medical device manufacturers

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  MEDEP JSC

  • Vietnam

  • Quality Assurance Engineer

    • May 2019 - Oct 2020
    • Vietnam

    Working in the quality assurance department, I have promoted the solving problem skill (be a member in investigation team for finding root cause, following the nonconformity related to resources); use appropriate methods to improve the efficacy of work (such as risk management).Attending the internal audit for finding the nonconformity and improve the quality system effectively; as well as the external audit which help the company get ISO 13485:2016 certificate.Improving the human resources procedure, such as editing training procedure, adding required training list; training related procedures for other colleagues.Participating in company’s projects: saving energy, reducing microbiological test sample in environmental monitoring, studying new detergent agent in cleaning…

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  MEDEP JSC

  • Quality and Regulatory Officer

    • Oct 2018 - May 2019

    Finding out more about the regulatory requirements of Vietnam and international for medical devices. Performing the Manufacturing Authorization registrationMoreover, implementation the related work for purchasing (supplier evaluation, following nonconformity of incoming quality control), which help me have basic overview about ISO 13485:2016.

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  Universal (HK) Technology Co.Ltd

  • Vietnam

  • Sales Engineer

    • Dec 2016 - Jan 2018
    • Vietnam

    Selling analytical equipment for laboratory, supporting develop both scientific and commercial skills by finding potential customers and achieving the sale targets.Following up the customer’s project: identifying what stage is it (proposal or bidding) by contact customer frequently via email/phone, supplying related information of the productsTaking part in ANALYTICA Exhibition 2017 as an organizer (represent for company), this is a chance for enhancing the potential customer list and their requirements

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  Sanofi

  • Analyst

    • Jul 2015 - Feb 2016

    Performing all the microbiological tests for products, gaining experiences in lab techniques such as media preparation, antiseptic technique, calibration for tool and equipment in lab… Collecting microbial sample for environmental monitoring, as well as for operational qualification in new plant