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Regulatory Authority, Ra/qa

1 month ago

หลกส กรงเทพมหานคร, Thailand Reeracoen Thailand Full time

**Overview**:
**Salary**:
30,000 THB ~ 50,000 THB**Industry**:
Medical, Manufacturing(Chemicals/Materials)- 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**:

- Regulatory Affairs