Principal R&D Scientist -免疫组化

l Responsible for RD IHC lab daily management.

l Responsible for RD documents (design control, sample management, materials management, etc.) generation and updates.

l Responsible for technical transfer and products upgrade testing and registration documents preparation.

Area of Responsibilities:

l Be responsible for IVD products translocation and development, including class 1, class 2 and class 3 in NMPA.

l R&D IHC lab management including materials, instruments.

l R&D documentation management based on regulation requirement.

l Work closely with cross functional team to drive the projects

l Work with global team for translocation projects.

l R&D materials/samples management.

Person Specification：

Strong capability in IHC products development; Strong knowledge in CDx regulations.

Strong knowledge of NMPA required R&D documents preparation.

Strong knowledge of regulatory requirements for medical device for the whole lifecycle.

Excellent knowledge of risk management related GMP, ISO standards, etc.

Excellent knowledge of medical device regulatory requirements related to design controls.

Good knowledge of DFMEA/PFMEA implementation.

Strong capability in PSP (Problem Solving Process) activities and driving good solutions.

Excellent English in verbal and written.

Excellence in prioritizing and comparing strengths and weaknesses from system level thinking.

Good team collaboration

Self-motivated