l 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.
l Reviews the Device Master Record, Design History File, Technical Files, and Source of Manufacturing changes.
l Provides guidance regarding the requirements of the QSR (for example, DHF, deliverables, SOPs, etc.).
l Concurs with the Project Core Team prior to commercialization of product (Regulatory must concur with the decision to pass Gate 3).
l Provides Regulatory Safety Testing Assessment (for example, EMC, 601-1, Risk Analysis, etc.).
l Establishes and maintains safety agency approvals (for example, UL, TUV, etc.).
l Coordinate Clinical Trial/ Trade Trial arrangement to meet regulatory compliance.
l Lead software product and copyright registration program at local software agency.
l Maintain domestic and worldwide standard list relative to safety, environment, EMC, software, product performance etc..
l Coordinate other business licence/ certificate program as appropriate.
公司信息：
锐珂（上海）医疗器材有限公司
Carestream Health 公司成立于 2007 年 ， 是位于加拿大多伦多的 Onex 公司收购伊士曼柯达公司医疗集团后组成的。 2006 年的总收入超过 25 亿美元 。
Carestream Health 公司 拥有 8,100 多名员工，为 全球 150 多个国家的数万名客户提供优质的医疗产品。公司拥有 1,000多项技术专利，产品在全球90%的医疗机构中运转。在 医疗信息管理解决方案（ KODAK Carestream Solutions ），数字获取解决方案（ KODAK DIRECTVIEW CR/DR System ），数字输出解决方案（ KODAK DRYVIEW System ）以及数字乳腺放射成像解决方案， 牙科及分子成像系统， 各种数字和传统 X 光胶片产品在内的多个领域中 ， Carestream Health 公司凭借丰富的整合方案以及专业全面的服务体系已经成为医疗数字成像市场的领导者。遍布全球的 1,150 名工程师和 250 名客户支持代理能够及时的对设备进行维护并作出快速响应。
Carestream Health 公司在中国成立了锐珂（上海）医疗器材有限公司和锐珂（厦门）医疗器材有限公司。依托柯达品牌百年来所积累的宝贵经验，通过充满激情、以客户为中心的团队，将不断追求技术发展和创新，为客户提供最新的医疗解决方案与技术，帮助从最小的诊所到最大的医院等各个医疗机构实现长期彻底的投资回报和应用保障。
Carestream Health, Inc., is an internationally successful company providing medical and dental imaging systems and information technology solutions; molecular imaging systems; and non-destructive testing products to a broad base of customers around the world.
Onex acquired the Health Group of Eastman Kodak Company in a multi-billion-dollar transaction in May 2007. Upon closing, the business began operating as a standalone company (i.e., Carestream Health, Inc.) that is an independent subsidiary of Onex Corporation of Toronto. Prior to becoming Carestream Health, Kodak’s Health Group recorded 2006 revenues of more than $2.5 billion. Carestream Health has more than 8,100 employees, serving tens of thousands of customers in more than 150 countries.
