Regulatory Affairs & Quality System Officer (Medical Devices – Import & Distribution)

Detail

【Job Description】
⎼ Assist in preparing medical device registration documents for submission to the Thai Food and Drug Administration (Thai FDA).
⎼ Review and ensure regulatory compliance of documents including Common Submission Dossier Template (CSDT), labeling, and Instructions for Use (IFU).
⎼ Monitor the progress of applications and assist in addressing inquiries or requests for information from the Thai FDA.
⎼ Coordinate with overseas manufacturers to collect and organize necessary regulatory and quality-related documentation.
⎼ Support the creation and management of Quality Management System (QMS) documents in accordance with GDPMD and ISO 13485 standards.
⎼ Assist in document control duties and support quality-related activities such as Complaint handling, Corrective and Preventive Actions (CAPA), and Post-Market Surveillance (PMS).
⎼ Assist in audit preparation and the maintenance of the quality management system.
⎼ Verify import documents including Invoices and Packing Lists to ensure accuracy and compliance.
⎼ Confirm the legality and compliance of Thai language labeling prior to product distribution.
⎼ Support lot management and product traceability, including the tracking of lot numbers and serial numbers.
⎼ Coordinate with internal and external stakeholders, including shipping, logistics, and sales departments.
⎼ Other related tasks as assigned.

【Qualification】
⎼ Bachelor’s degree or higher in Biomedical Engineering, Medical Technology, Pharmacy, Science, Biotechnology, Nursing, Health Science, Engineering, or other related fields.
⎼ Open to junior candidates or fresh graduates (20s) with a strong interest in Regulatory Affairs (RA) and Quality Assurance (QA) within the medical device industry.
⎼ High proficiency in English reading and writing, specifically for handling technical and regulatory documentation from overseas.
⎼ Proficient in basic Microsoft Office applications.
⎼ High learning agility with the ability to quickly absorb and apply new knowledge and business processes.
⎼ Highly responsible with strong attention to detail and accuracy.
⎼ Excellent organizational skills with the ability to prioritize tasks effectively.
⎼ Strong communication and interpersonal skills for effective internal and external coordination.
⎼ Proactive mindset with a strong motivation for continuous professional growth and learning in the medical device sector.

【Allowance & Benefit】
-SSO
-Annual health check-up
-Personal Computer ＆ Phone
-Bonus *depends on the company sales and performance
-Company Trip *depends on the company sales and performance

【Working Hour】
Mon. - Fri. 8:00 -17:00