刘女士 is a RA at 赛默飞世尔科技.
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Ra赛默飞世尔科技 Apr 2021 - Present中国 江苏省 苏州Project Objective: Transfer US product projects to Chinese factories.Responsibility: Regulation and monitoring China local product related certificate to obtain and maintain, communication with different department to provide regulatory guidance in product lifelong, including registration requirements, labeling requirements, the registration timeline, responsible for the planning and implementation of the Chinese factories registered activity, is responsible for NMPA regulations, registration activities planning and implementation of clinical. Responsible for the resource planning of the registration task and guide the related personnel to carry out various activities, liaise with NMPA, timely submit registration dossier to the competent authorities.Transfer project:1. NGS, from America to Guangzhou factories. Class III;2. Biosafety cabinet, from Germany to Suzhou factories. ClassIII;3.IDD(Allergy) from Sweden(Fadia)to Guangzhou site.Class II;4. Frozen refrigerator ,from America to Suzhou site.Class II -
Ra Manger江苏鱼跃医疗设备股份有限公司 Oct 2016 - Apr 2021中国 江苏省 苏州Project Objective:Complete all product registration with R&DResponsibility: Regulation and monitoring China local product related certificate to obtain and maintain, communication with different department to provide regulatory guidance in product lifelong, including registration requirements, labeling requirements, the registration timeline, responsible for the planning and implementation of the Chinese factories registered activity, is responsible for NMPA regulations, registration activities planning and implementation of clinical. Responsible for the resource planning of the registration task and guide the related personnel to carry out various activities, liaise with NMPA, timely submit registration dossier to the competent authorities.The completed project:NMPA:1.16 products(electrical equipment) obtained registration certificates.2. 5 sterile medical devices obtained registration certificate.FDA:2 products obtained 510k .CE:2 products obtained CE mark and 1 Declaration of conformity..another countries, such as : TGA, Russia
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RaEthealthcare Apr 2013 - Oct 2016中国 江苏 苏州
Frequently Asked Questions about 刘女士
What company does 刘女士 work for?
刘女士 works for 赛默飞世尔科技
What is 刘女士's role at the current company?
刘女士's current role is RA.
What schools did 刘女士 attend?
刘女士 attended 武汉大学.
Who are 刘女士's colleagues?
刘女士's colleagues are Sruthi Thelakkat Chathoth, Lucia Favila Humara, Haynes Mark, Amaya Gómez De Vírgala, Libby Pupanek, Joseph Ong, Sheena Suchak Fcca Fpac.
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