- 工作地点：上海
- 职位：Regulatory Affair Officer
- 信息来源：中华英才网
说明：
-Provides assessment regarding compliance for all local and international regulatory requirements for product commercialization. Creates and manages regulatory submissions including, but not limited to, 510(k), PMA, Letter to File, MDD technical files. 此信息由中华英才网审核并发布（查看原发布网址），应届生求职网转载该信息只是出于传递更多就业招聘信息，促进大学生就业的目的。如您对此转载信息有疑义，请与原信息发布者中华英才网核实，并请同时联系本站处理该转载信息。
-Reviews the Device Master Record, Design History File, Technical Files, and Source of Manufacturing changes.
-Provides guidance regarding the requirements of the QSR (for example, DHF, deliverables, SOPs, etc.).
-Concurs with the Project Core Team prior to commercialization of product (Regulatory must concur with the decision to pass Gate 3).
-Provides Regulatory Safety Testing Assessment (for example, EMC, 601-1, Risk Analysis, etc.).
-Establishes and maintains safety agency approvals (for example, UL, TUV, etc.).
-Coordinate Clinical Trial/ Trade Trial arrangement to meet regulatory compliance.
-Lead software product and copyright registration program at local software agency.
-Maintain domestic and worldwide standard list relative to safety, environment, EMC, software, product performance etc..
-Coordinate other business licence/ certificate program as appropriate.
-www.yingjiesheng.com@-
左手拥抱了一堆东西、 右手拥抱了另一堆东西、但是地上还有一堆东西。我想伸手再取一些,结果所有的东西都洒满了一地.. [摘自 一首古老的诗]
