RA Egineer job opportunity at Zeiss Group.



DateMore Than 30 Days Ago bot
Zeiss Group RA Egineer
Experience: General
Pattern: full-time
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degreeGeneral
loacation Guangzhou, China
loacation Guangzhou....China

5 年国产三类医疗器械 RA 工作经验,具有眼科医疗器械注册经验优先。 熟练掌握 NMPA 医疗器械相关法规、标准和指导原则,能够准确解读法规要求。 三类医疗器械注册申报和获批经验 : 能够熟练起草注册申报资料,协助编写临床评价报告,确保资料真实且合规 ; 能够熟练开展与审评专家的沟通,跟进审批进展,协调解决审评问题。 三类医疗器械注册检测和委托检测经验: 熟悉产品注册和委托检测相关流程和要求, 能够熟练与检测中心专家沟通,跟进检测进展,并高效解决检测问题。 三类医疗器械复杂变更注册经验。 良好的跨部门协作能力和良好的团队合作精神。 可作为工作语言的中、英文听说读写能力。 无 Your ZEISS Recruiting Team

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