หน้าที่ความรับผิดชอบ

KEY RESPONSIBILITIES
- 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 representing of clients which is not limited to renewal, amendment, and importation tasks.
- Accountable for importation activities including LPI preparation.
- Undrstand local and ASEAN medical device regulationss, 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.
- Ensure activities is in accordance with GDPMD.
- Performing various other tasks as assigned by supervisors.