宜昌招聘

Regulatory Affairs Specialist/Sr. Regulatory Affairs Specialist

Job Summary

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.

Responsibilities

• Be responsible for registration dossier preparation and submission based on product launch planning and CFDA requirement.
• Be responsible for registration test protocol preparation and work closely with testing lab to perform the registration test based on registration planning and authority requirements.
• Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.
• Follow up closely with CMDE and NIFDC, and report the progress of product registration.
• Build good network with relevant governments such as CFDA, NIFDC, and testing labs.

根据产品的启动计划和CFDA的要求，负责注册文件的准备和提交。

负责注册测试的准备工作，并与测试实验室紧密合作，根据注册计划和权威要求进行注册测试。

根据注册文件和注册测试的需要和问题，与总部进行紧密的沟通。

与CMDE和NIFDC密切合作，汇报产品注册的进展情况。

与相关的政府部门建立良好的网络，如CFDA，NIFDC和测试实验室。

Required Knowledge, Skills, and Abilities

• Bachelor’s Degree or above of Medical related major.

• Minimum of 1 year experience on medical device or drug registration , preferably on IVD registration.

• Skill of performing testing in lab. Experience on R&D or Lab testing work is preferred.

• Good English & communication skills.

• Knowledge of GCP and CFDA guidelines.

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 ***************.