岗位职责:

1. Responsible for the coordination of conformity assessment and all relevant activities under client application for IVD manufacturer according to related certification scheme (e.g. CE certification and QMS certification) and ISO/IEC 17021 requirements (10%)

2. Conduct auditing in IVD manufacturer according to QMS standard requirements (ISO 13485 and ISO 9001), regulatory requirements (e.g. IVDR and MDSAP), procedures and code of conduct (60 %)

3. Communication interface for the customer regarding the assigned conformity assessment (10%)

4. Support sales and marketing activities in technical issues and bring potential business information (10%)

5. Perform other duties assigned by regional manager or IVD manager. 10%

任职条件:

1. Bachelor or above degree in Biology/ Biochemistry/ Chemistry /Biotechnology/ Molecular Biology/ Pharmacy or Immunology.

2. Minimum 4 years working experience in the fields of in vitro diagnostic medical device design, manufacturing, inspection, clinical study and regulatory affairs.

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 and travel frequently

6. Respect and safeguard company’s image, reputation and benefit;