Regulatpry Affair Officer

รายละเอียดงาน

1. - Prepare and submit medical device documents for registration to Thai FDA and ASEAN authorities. - Manages product certificates and performs other tasks related to in-country representation of clients which is not limited to renewal, amendment, and importation tasks. - Accountable for importation activities including LPI preparation. - Understand local and ASEAN medical device regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and other related documents. - Report updates and provide support to the project team. - Provides local regulatory updates to business team regarding medical device regulations. - Providing support in terms of product importation by ensuring that all documents are aligned with local requirements. - Investigate proactively and capitalizing regulatory information collected throughout studies and maintain regulatory databases accordingly. - Ensures activities is in accordance with GDPMD. - Performing various other tasks as assigned by supervisors.

เวลาทำงาน

1. 07:00 - 16:00

คุณสมบัติ

1. เพศ: ไม่จำกัด ช่วงอายุ: 23 - 30 ปี วุฒิการศึกษา: ปริญญาตรี

สวัสดิการ

1. Benefits: Medical, Bonus, Miscellaneous allowance

ที่อยู่

สาขาหลัก จอมพล จตุจักร กรุงเทพมหานคร 10900