Are you ready to embark on an exciting professional journey where innovation, collaboration, and excellence are at the heart of everything we do? Look no further! We are seeking passionate individuals like you to join our dynamic team.

I.     Position Summary

This position is responsible for performing product and technical documentation assessment in the field of In Vitro Diagnosis (IVD) devices and delivery the assessment result to support the certification decision.

II.     Job Responsibilities

1. Perform CE technical file assessment according to regulation (e.g. IVDR and IVDD), common specification and standard requirements. (75%)
2. Communication interface for the customer regarding the assigned conformity assessment (10%)
3. Support IVD auditor for the whole conformity assessment project planning (5%)
4. Support sales and marketing activities in technical issues and bring potential business information (5%)
5. Perform other duties assigned by regional manager or IVD manager (5%)

III.     Job Requirements

1. Bachelor in Biology/ Biochemistry/ Chemistry / Biotechnology/ Molecular Biology/ Pharmacy or Immunology. Master degree is preferred.
2. Minimum 5 years working experience in the fields of in vitro diagnostic medical device, (e.g. IVD reagent, test kit, software and instrument) design / production / product quality control or similar working experience.
3. Diligence, strong teamwork spirit and good independent learning capability.
4. Good computer skill and good command of English (Written-fluent, oral-medium);
5. Can work independently and efficiently; Able to work under pressure.
6. Respect and safeguard company’s image, reputation and benefit;