工作职责:
1.Establish and implement corporate regulatory policies and procedures to assure compliance with applicable international regulations and standards.
2.Work with internal regulatory resources, external distributors, and external consultants to obtain Ministry of Health agency product registration requirements.
3.Provide guidance on Ministry of Health requirements to obtain marketing approval for products in all countries in which products are to be sold.
4.Assist in training on medical device regulations.
5.Legalize documents as required for product registrations and tender bid activities
6.Prepare dossiers for international Ministry of Health product registrations/approvals.
7.Maintain documentation system to assure all Carestream associates (regulatory, sales, marketing, etc.) have access to registration, license, permit, etc. documents as required for Ministry of Health registrations, sales and marketing support.

任职资格:
1.A BS, or equivalent experience, in science, engineering, international business, foreign language or other relevant discipline.
2.Excellent communication both in English and Mandarin
3.At least 3 years regulatory experiences, good at entire registration process.
4.Demonstrated experience in X-Ray Medical Devices is preferred.
5.Experience related to EU and FDA regulations on registration is preferred.
6.Have good Analytical Thinking and Problem Solving skill
7.Have good communication skills

Carestream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组成的，简称锐珂医疗,自其一成立就立即成为世界上最大的医疗成像和信息技术（IT）公司。公司拥有8,000 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、X射线解决方案、数字输出解决方案以及数字乳腺放射成像解决方案、牙科及各种数字和传统X光胶片产品在内的多个领域中，Carestream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。