Our client is a global medical device company who provides consumable products to hospitals.
Job Description
Supporting any Quality Regulatory Compliance related special projects that are assigned by company policy as well as by the change of Thai FDA regulation and requirement.Preparing, registering, and gathering documents related to the registration process to get both new and renewed 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).Incorporating with QA/RA manager to oversee the changes and/ or new legislation, requirements, applicable standard, and/ or requirement that lead to impact on the registration process and Quality Management System.Gathering, filing, and maintaining all data/information regarding FSCA, AE, Customer Complaints, and any other rel...