Back

SHD Technology Regulation Specialist

Job Description

Mission/Position Headline:       

This role provides technology supporting to China RA registration process. Be an interface with Headquarter, Shanghai plant technology department and NIFDC (National Institutes for Food and Drug Control).

Areas of Responsibilities:           

•             Get knowledge of international best practice of RM development and standard establishment process, and get familiar with NMPA corresponding process, in order to enhance the collaboration between Siemens technical dept. and NMPA.

•             Act as a local key contact window to connect NIFDC and TC136 (Authority of China RM development and YY/T drafting), and other authority as well

•             Proactively work with US R&D center and provide technology support to RA and work with RA trying to sort out technical issue.

•             Maintain China Technology Regulation Standard sharepoint, timely consolidate/upload/collect comments of NMPA updated policy and get validation data archived and can be tracked well

•             Other related projects or tasks assigned by supervisor or company.

Requirements:

•             Master degree in Biology, Chemistry, Biochemistry or Life Sciences related.

•             Fresh student or 1+ years job related experience

•             Good understanding and knowledge of IVD technology, as well as experience with experiment

•             Have a digital mindset and proficiency in Microsoft Office Applications and statistics software, like Word, PPT and etc.

•             Strong self-motivation to work independently and to effectively prioritize and manage multiple assignments.




Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Part-time

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?