Responsibility：
61 Coordinate and execute China registration type testing for FMC all active medical devices in house or in national test labs.
61 Technical supporting for FMC all active medical devices China registration, including technical issues clarification, dossiers preparation, onsite audit supporting and NMPA technical consultation and explanation.
61 Regulatory verifications within different business units, mainly focus on product safety, EMC, and system compliance test.
61 Maintain ISO/IEC 17025 certificate and execute ISO/IEC 17025 activities.
61 Execute testing activities and preparing technical documents such as test method uncertainty report, test report, etc
61 Execute equipment procurement, acceptance, calibration, intermediate check, maintenance, etc
61 Execute all quality control activities, such as proficiency testing, interlaboratory comparison testing, personnel comparison testing, etc
61 Participate in the drafting activities of Chinese standards for HD and relevant products. To be the bridge between global and China, to ensure FME products meet Chinese standards requirements.
61 Establish and maintain good relationship with national laboratories; Work with national laboratories and NMPA to obtain product approval.

Requirement：
61 BS or MS in EE/ME/BM Engineering or related filed
61 Minimum 5 years in Medical R&D related area (Prefer HD area)
61 Able to work efficiently under high pressure and constrained time requirement
61 Self-motivated, excellent communication skills, and a good team player
61 Well organized, proactive, initiative, analytics skills.
61 Familiar with GB9706.1, YY9706.102, YY9706.108, GB14710 or corresponding IEC standard etc.
61 Skilled in the use of safety tester, oscilloscope and other instruments and equipment, can complete the test independently
61 Experience in medical device products registration. Class III medical device products registration work experience is a plus
61 Familiar with QMS related standard (ISO 13485, ISO17025 etc.)
61 Strong English verbal and written communication skills.

To02ensure02the02equal02employment02rights02of02every02candidate,02Fresenius02Medical02Care02China,02as02a02"Top02Employer,"02is02committed02to02actively02taking02actions02to02implement02the02DE&I02(Diversity,02Equality,02Inclusion)02and02company02purpose.02This02aim02to02ensures02that0202Minorities/Females/Veterans/Disability/Sexual02Orientation/Gender02ldentity02have02equal02employment02opportunities.
为保障每一位候选人的平等就业权利，费森尤斯医疗中国作为“杰出雇主”，承诺在招聘和雇佣过程中积极采取行动践行“DE&I（多元、平等、包容）”理念，以确保***、少数族裔、退伍军人、残疾人和不同性取向和性别身份的个体等都能够获得平等就业机会。