北京招聘

Job responsibility:

?Manage all regulatory activities associated with the registration & support of new and approved Medical Device (IVDs) products
?Supervise the identification and compilation of required documentation for submission.
?Evaluate the adequacy of the content of regulatory submissions and identify deficiencies requiring further resolution.
?Coordinate new product launched into China by identifying potential RA issues
?Oversee the regulatory compliance in certain fields, such as BSE/TSE…
?Third Party communications and management (CRO, Laboratories and other service providers)
?Support Department Head to maintain communication channels / relationships with relevant authorities (include but not limited as SFDA, MOH, AQSIQ and their offices…)
?Answer inquiries of customers about RA issues
?Other responsibilities assigned by the Department Head

Qualifications：
- A minimum of Bachelor’s Degree in any life science discipline or the equivalent, such as medical / bioengineering / medical laboratory / pharmaceuticals
-Having 2-3 years regulatory experience in relevant Industries (Biotechnology, Medical Device / IVDs…)
-Fluent English
-Interpersonal / networking skills
-Initiative and self-motivation

Merck – Living Innovation
默克 – 创新引领生活

默克是一家全球领先的医药与化工公司，以创新和高科技优质产品闻名世界。

默克在全球66个国家与地区拥有约38,000名员工，致力于改善患者的生活质量，助力客户实现长远的成功和迎接全球化挑战。

默克旗下四大业务分支——默克雪兰诺、消费者健康、功能性材料和默克密理博——2012年总收入达112亿欧元。

默克是全球历史最悠久的医药与化工公司。自1668年起，默克就成为了创新、成功和负责任的企业家精神的代名词。默克家族作为公司的创始人至今仍持有默克大部分的股份。

我们是默克，正根正源，在全球拥有“默克”这一名称和品牌的所有权。唯一的例外是在美国和加拿大，我们使用“EMD”的名称。
Merck – Living Innovation

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors.
Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.
We generated total revenues of