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
5 active jobs
Gothenburg
Industry:
Other
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