工作職責(zé):
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(gòu)伊士曼柯達(dá)公司醫(yī)療集團(tuán)組成的，簡(jiǎn)稱銳珂醫(yī)療,自其一成立就立即成為世界上最大的醫(yī)療成像和信息技術(shù)（IT）公司。公司擁有8,000 多名員工，為全球150 多個(gè)國(guó)家的數(shù)萬(wàn)名客戶提供優(yōu)質(zhì)的醫(yī)療產(chǎn)品。公司擁有1,000 多項(xiàng)技術(shù)專利，產(chǎn)品在全球90% 的醫(yī)療機(jī)構(gòu)中運(yùn)轉(zhuǎn)。在醫(yī)療信息管理解決方案、X射線解決方案、數(shù)字輸出解決方案以及數(shù)字乳腺放射成像解決方案、牙科及各種數(shù)字和傳統(tǒng)X光膠片產(chǎn)品在內(nèi)的多個(gè)領(lǐng)域中，Carestream憑借豐富的整合方案以及專業(yè)全面的服務(wù)體系已經(jīng)成為醫(yī)療數(shù)字成像市場(chǎng)的領(lǐng)導(dǎo)者。