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SHD Sr. RA Specialist

Job Description

Mission/Position Headline:          

Support RA Manager in all activities.  Fast and efficient registration and promotion of responsible product lines (Instruments and reagents) to be sold in China. 支持法规经理的所有工作,快速和高效的完成所负责产品线计划在中国销售产品(仪器和试剂)的注册及上市工作。

Areas of Responsibilities:

Transact all product licenses needed to do business.  办理业务所需的所有产品注册证

Take care product-specific and general regulatory deadlines.  监督各项产品的注册时限, 整体注册时限

Prepare documents and files to contact states authorities and organize business contacts, work on timely    and legally correct delivery of all necessary registration material for SHD products.  准备文件和档案,以及时、合法、正确的方式递交公司产品注册所须的资料。负责联络相关政府机构,联系相关业务活动。

Reports process and document failures to the respective departments and handles the data update, substitution and also translation matters together with the respective dept. 向相关部门报告产品注册进程及文件不合格状况,通过与各部门合作处理文件数据的更新、替换及翻译等事务。

Works on reporting critical issues to Management.  向管理层报告紧急、危机事件

Support market research on planned government and competition activities. 根据政府计划及竞争活动的安排支持市场研究.

Daily working with our international Regulation affairs colleagues using our existing data pool.  通过使用现有的资料库与公司全球法规和注册事务方面的同事保持日常合作。

Other related projects or tasks assigned by supervisor or company. 其它上级或公司指派的项目或任务。

Requirements:

• Ecsomatics background, good experience in RA within medical device or pharm industry Adequate knowledge about diagnostics products and its major feastures. Proven registration success record.

• Be able to complete the registration work independently, including registration type-testing, document preparation, internal and external communication.

• At least 3 years RA experience, knowledge in NMPA regulations and rules,  with Diagnostics/medical/ biological background education.            

• Effective communication skills both written and verbal            

• Is highly computer literate with good experience in using Microsoft Office applications            

• Has a thorough knowledge of Company Procedures and Policies            

• Good understanding of the Financial system operated within the company            

• A broad based knowledge of the products within the In-Vitro Diagnostics industry            

Relevant and demonstrable knowledge of the market in which MED DX operates




Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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