宜昌招聘

职位描述：
Reporting to: Manager, Clinical Business Unit

Work Location: Beijing / Shanghai

PURPOSE:
This position is responsible for implementing company regulatory policy and procedure, preparing SFDA submission documents in a timely and high quality manner.

KEY RESPONSIBILITIES:

? Prepare and follow through the complete process of product registration with the SFDA and other Chinese Government departments
? Set up company RAQA procedures
? Work with the sales/marketing team to plan and prioritize the product registrations and to assist in resolving any issues and problems that may arise in the field.
? Help company develop close relationships with Government Departments and Officials to facilitate the implementation of product registration strategies.
? Handle post market quality issues like product complaints, Adverse event reporting and recall
? Update quality files like Chinese labels and Manuals database to be compliance with SFDA regulations
? Give medical device regulatory trainings to Sales / Marketing/ Dealers
? Work with Legal to assist business licesne update
? Lead the application of distribution license if necessary
? Lead and pass local FDA audit

REQUIREMENT:
? BSc or Master’s Degree in chemistry, pharmacy or related
? Min 5 years’ experience in pharmaceutical industry or related industry like medical devices or healthcare industry
? Have or acquire in-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and devices and understand its interpretation as well as Regulatory Corporate policies
? Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy
? Good knowledge of written and spoken English
? Competent project management skills; Ability to handle multi-task activities
? Good oral/written communication & interpersonal skills
? Ability to handle conflict; initiative and negotiation skills
? Good understanding of the Chinese and global regulations 举报 分享

丹纳赫是全球科学和技术的创新者，致力于帮助我们的客户在全球各地应对复杂的挑战和改善生活品质。我们在最前沿和富有吸引力的领域，如生命科学、环境等等，拥有众多世界一流的品牌。我们是一支全球超过71000名员工的多样化团队，遵循同一个文化 - 丹纳赫业务运营体系（DBS）,该体系引领我们始终在日益激烈的商业竞争中处于领先地位。丹纳赫2014年营业额达到199亿美金并且市值超过600亿美金，位列美国财富500强中的149位。在过去的20年中，丹纳赫的股价表现优异，超过标准普尔指数将近2000%。

在中国，丹纳赫始终保持高速增长，拥有超过6000名员工和16亿美金的营业额。二十多家中国营运公司和超过一百家的分支机构，不但为中国客户提供着全方位的产品和服务，也为卓越人才提供更好的工作机遇和职位发展平台。

了解更多信息，请访问公司网站：***************.

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including health care, environmental and etc. We are a globally diverse team of 71,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. In 2014, we generated $19.9 billion in revenue and our market capitalization exceeded $50 billion. We are ranked #149 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,000 percent.

With over 6000 associates and $1.6 billion of revenue in China, Danaher continuously achieve high growth in the market. Through more than 20 China operation companies and more than 100 subsidiaries, Danaher not only provides comprehensive products and services to China client, but also better career opportunities and development platform for talents.

For more information please visit our website at ***************.