บริษัท แมนพาวเวอร์ จำกัด (สาขาบางนา)

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Regulatory Affairs Officer (RAO) ปฏิบัติงานนิคมอุตสาหกรรมบางกระดี่ (จ- ศ)

Oct 2, 2026

Location

Bangkadi Industrial Park (BIP) Pathum Thani

Salary

25,000 - 30,000 THB

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Job Descriptions

Job Description - Thai FDA Compliance: Manage import/export licenses, product variations, renewals, vigilance reporting, export certificates, and GDPMD gap analysis. - International Registrations: Prepare CSDT dossiers (AMDD), perform EUDAMED registrations, and liaise with APAC/Global RA teams for market approvals. - Product Specifications & Labeling: Develop FG/Semi-FG specifications, verify BOMs, register UDI-DI/GTIN with GS1 - Thailand, and validate Thai artwork/IFUs. - Quality & Documentation Support: Assist with customer complaints, internal deviations, change control procedures, vendor artwork coordination, and ISO 14001 implementation. Working : Monday - Friday (Office Hour)

Qualifications

Education: Bachelor's degree in any field or higher vocational certificate
Experience: Minimum 2 years in QA or RA (medical device industry preferred)
Language & IT: Good command of English; computer literate
Knowledge: ISO 13485, Thai FDA regulations, GDPMD, ISO 14001
Competencies: Detail-oriented, strong problem-solving skills, positive attitude, and ability to work cross-functionally
Can communicate in English to work with international RA
Have experience in RA-Thai FDA and prefer if have experience to work international RA