Regulatory Affairs (Medical Devices) ปทุมธานี ยินดีรับนักศึกษาจบใหม่ [JO34198]

หน้าที่และความรับผิดชอบ

• 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.

คุณสมบัติ

คุณสมบัติด้านความรู้และความสามารถ

• Female and Male,22-28 years old.
• Bachelor’s degree or higher in Biomedical Engineering, Medical Technology, Pharmacy, Science, Biotechnology, Nursing, Health Science, Engineering, or other related fields.
• New graduates are welcome.
• Have Regulatory Affairs (RA) and Quality Assurance (QA) within the medical device industry.
• English intermediate level.
• Proficient in basic Microsoft Office applications.
• High learning agility with the ability to quickly absorb and apply new knowledge and business processes.
• Proactive mindset with a strong motivation for continuous professional growth and learning in the medical device sector.

สวัสดิการ

• ตามข้อตกลงของบริษัท
• ประกันสังคม
• เงินโบนัสตามผลงาน
• ทำงานสัปดาห์ละ 5 วัน
• สิทธิการเบิกค่าทันตกรรม

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การเดินทางเพิ่มเติม : บางนาตราด ก.ม.16