霖 李
注册部总监 @ 苏州景昱医疗器械有限公司
About
想追求更好的自己
Country
China
City
Suzhou
Industry
Medical Device
Skill
三类有源植入医疗器械注册, 医疗器械创新申报, 医疗器械合规, 医疗器械CE, 项目管理
Experience
注册部总监
苏州景昱医疗器械有限公司
2010-7 - Present · 16 yrs 3 mos
苏州
负责法规部整体事务，包括预算，工作计划与执行等。 研发期、检测期、注册期的法规工作的流程建立及优化。 完成两次国家医疗器械绿色通道的申请并通过。 完成六个三类有源植入式医疗器械的注册工作。 完成六个二类有源医疗器械注册工作。 带领团队根据需要完成各产品的变更工作，生产许可证的相关变更工作，以及海外注册资料准备。
霖 李's Contact Information
******@***.com
Phone
(**) *** ****
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