QA/ra

7 hours ago


หลกส กรงเทพมหานคร, Thailand บริษัท นิโปร เซลส์ (ประเทศไทย) จำกัด Full time

**Role & Responsibility**:

- 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).
- 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.
- 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.

**Knowledge/Skills/Experience**:

- Bachelor’s Degree in Science, Medical or related fields.
- 2-3 years of experience in Medical Device products registration process or related field.
- Knowledge of registration process and/ or DCC for any applicable QMS is a must. (ISO13485)
- Good command in English & Thai both written and spoken.
- Good computer literacy (MS Office: Word, Excel, Access, and Power Point).

ประเภทของงาน: งานประจำ



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