Regulatory Affair Officer
ประกาศงานเลขที่ : TJ20060090-0001
อัพเดทล่าสุด : 30/06/2563
ประเภทธุรกิจ: ธุรกิจ ที่ปรึกษา
Qualtech is an Asia Medical Device Regulatory and Clinical Trial (CRO) Company founded in 2000 and has established its own companies in Taiwan, China, Singapore, Malaysia, Philippines, Hong Kong, Indonesia, Japan, Vietnam and most recently in Germany. Qualtech’s brand of service resides in the idea of providing exceptional service to foreign manufacturers with a wide range of medical device regulatory advices in a precise and timely manner.
Qualtech Thailand is looking for enthusiastic and talented candidates who will join our organization and deliver excellent medical device regulatory expertise in Thailand as well as other ASEAN countries. The qualified candidate will be mainly responsible to handle and support product registration related activities in multiple countries. He or she shall also assist in catering to the in-country representation needs of clients.
- 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.
- 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.
- Bachelor’s degree in Pharmacy, Pharmaceutical sciences, Medical Engineer, Biomaterials, Biochemistry or related fields from a reputable university.
- Minimum 1 years of regulatory experience, preferably in the medical device industry.
- However, Fresh graduates are encouraged to apply.
- Proficient in English.
- รัตนาภรณ์ ชูวัฒนเกียรติ
- Regulatory Affair
- Tel : 02-026-0502
Email : เลื่อนเพื่อดูอีเมลเพิ่มเติม
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