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    Senior/ Quality Regulatory Compliance Specialist

    Full-Time
    , Thailand
    Posted: August 23, 2024
    Position Details

    Day to day responsibilities will include:


    • Do prepare, register, and gather documents related to registration process to get both new and renew import licenses e.g. Certificate of Free Sale/ Certificate of Goods/ Free Sale Certificate, ISO/ any other applicable standard certificate, product catalogue/ brochure, Instruction for use/ Notice, and declaration letter (if needed).
    • Do support any QRC related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement.
    • Incorporate with QRC manager to oversee the changes and/ or new legislations, requirements, applicable standard and/ or requirement that lead to impact to registration process and Quality Management System.
    • Do gather, file, and maintain all data/ information regarding FSCA/ AE/ DD/ Customer Complaint and any other related QRC issues.
    • Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System .


    Your Experience Includes


    • Bachelor’s degree in science background or related field.
    • 3-5 years of experience in Medical Device products registration, Pharmaceutical or related field.
    • Knowledge of registration process and/ or DCC for any applicable QMS is a must.
    • Good command in English & Thai both written and spoken.
    • Good computer literacy (MS Office: Word, Excel, Access, and Power Point).
    • Good coordinator, relationship, and communication skill with other departments
    • Good interpersonal skills and service orientation.
    • Ability to do multi-tasks & manage priorities under pressure .



    Skills
    Medical device
    DCC
    Pharmaceutical
    Interpersonal Skills
    Computer Literacy

    Functions
    Research & Development

    Job Overview

    Job Type:

    Full-Time


    Company

    Getinge  logo

    Getinge

    5 active jobs

    Industry:

    Other

    Ready to Apply?

    Submit your application now and take the next step in your career journey.

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