I. GENERAL SUMMARY & OVERALLCHALLENGES

In this role, you will prepare and arrange the registration test, prepare the submission dossier, submit and follow up the whole registration process. The major responsibility of the position is working on product registration on time according to the priority of products defined by the executive team of the company.

II. KEY RESPONSIBILITIES

1.Responsible for registration dossier preparation and submission based on product launch planning and CFDA/NMPA requirement.

2.Responsible for registration test protocol preparation and work closely with testing lab to perform the registration test based on registration planning and authority requirements.

3.Communicate closely with BU on the needs and problems of registration document and type test.

4.Follow up closely with CMDE and testing lab. And report the progress of product registration.

5.Support other functions on RA issues

III. REQUIREMENTS FOR THIS POSITION

a) Professional Experience

· At least 5 years’ RA experience in medical device.

· Experience in active medical device registration is preferred.

· Experience in drafting CER (Clinical evaluation report) is preferred.

b) Education

· Bachelor’s degree in biomedical engineering, clinical medicine, life science or related field.

· Master’s degree is preferred

c) Language

· Workable English skills

d) Travel (required estimated % of time)

15%

IV. PERSONAL TRAIT PROFILE

1.Good organization, good time management skill and effective communication skill

2.Trouble shooting and problem-solving skills

V. KEY RELATIONSHIPS

a) Internal

· Report directly to RA Manager

b) External

· Build good working relationship with relevant authorities such as CFDA, CMDE, NIFDC.

作为全球500强美国丹纳赫集团旗下知名公司之一的徕卡显微系统，是显微镜和科学仪器领域的全球先驱。公司开创于十九世纪，从家族企业发展至今已有160多年历史。如今的徕卡已成为全球知名企业，以无可匹敌的创新精神延续辉煌历史。
 
徕卡显微系统总部设在德国的韦茨拉尔 (Wetzlar)，在全球 100 多个国家设有代表处，在 7 个国家设有 12 个制造基地，在 20 个国家设立了销售和服务机构，并且设有全球性的代理商网络。
 
自1995年进入中国以来，始终秉承"与用户合作，使用户收益"的宗旨，凭借业界领先的产品性能和系统全面的解决方案， 成为了中国显微镜行业中的佼佼者。公司涉及的领域有生命科学研究、工业和医疗手术。
 
截止2013年底，徕卡在中国已有7家办事处，销售和服务网络涵盖了包括香港在内的16个区域，年销售额超过1亿美元。在上海建有生产基地和研发中心，员工超过300名，生产总额超过2500万美元。


Leica Microsystems, as a member of Danaher Group in the USA, which ranks the Fortune 500, is a world leader in microscopes and scientific instruments. It has been 160 years since the family enterprise was founded in the nineteenth century. The Company’s history was marked by unparalleled innovation on its way to becoming a global enterprise.


Leica Microsystems is headquartered in Wetzlar, Germany. The company has established offices in more than 100 countries, 12 manufacturing facilities in 7 countries, with sales and service organizations in 20 countries as well as global dealer network.
 
The company has become the leader in China microsystem industry with its leading products and systematic and comprehensive solutions with the commitment of “Cooperate with the customer and benefit the customer” since it came into China market in 1995. At global level, Leica Microsystems is organized in three divisions, Life Science, Industry and Medical.
 
As of the end of 2013, Leica Microsystems has established 7 offices in China with sales and service network covered 16 regions including Hong Kong. The annual revenue exceeded $ 100 million. The company has manufacturing facility and R&D center in Shanghai with more than 300 employees and over $ 25 million production.公司网站：**************************