岗位职责:

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%)

任职条件:

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;