Regulatory Authority, RA/QA (Medical Product) ID:68121

30,000 THB ~ 50,000 THBLak Siabout 1 month ago

Overview

  • Salary

    30,000 THB ~ 50,000 THB

  • Industry

    Medical, Manufacturing(Chemicals/Materials)

  • Job Description

    - Support any Quality Regulatory Compliance related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement.
    - 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 catalog/ brochure,
    - Instruction for use/ Notice, and declaration letter (if needed).
    - Incorporate with QA/RA 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.
    - Gather, file, and maintain all data/ information regarding FSCA/ AE/ Customer Complaint and any other related QA/RA issues.
    - Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System.

Qualifications

  • Requirement

    - Bachelor’s Degree in Science, Medical or related fields.
    - 1-3 years of experience in Medical Device products registration process or related field.
    - Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
    - Understanding of the rules and regulations medical products.
    - Strong problem-solving and prioritization skills
    - Knowledge of registration process and/ or DCC for any applicable QMS (ISO13485).
    - Good command in English & Thai both written and spoken.
    - Good computer literacy (MS Office: Word, Excel, Access, and Power Point).

  • English Level

    Level 3 - Business Level

  • Other Language

    Thai, English

Additional Information

  • Benefit


    - Provident fund 5%
    - Medical insurance AIA
    - Annual leave
    - Performance bonus

  • Working Hour

    9.00 ~ 18.00

  • Holiday

    Sat - Sun, Public holiday

  • Job Function