工作職責:
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.

任職資格:
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是位于加拿大多倫多的Onex公司收購伊士曼柯達公司醫療集團組成的，簡稱銳珂醫療,自其一成立就立即成為世界上最大的醫療成像和信息技術（IT）公司。公司擁有8,000 多名員工，為全球150 多個國家的數萬名客戶提供優質的醫療產品。公司擁有1,000 多項技術專利，產品在全球90% 的醫療機構中運轉。在醫療信息管理解決方案、X射線解決方案、數字輸出解決方案以及數字乳腺放射成像解決方案、牙科及各種數字和傳統X光膠片產品在內的多個領域中，Carestream憑借豐富的整合方案以及專業全面的服務體系已經成為醫療數字成像市場的領導者。