SHD RAQS Regulatory Specialist
We at Siemens Healthineers™ are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization:
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。
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
• At least 3 years RA experience, knowledge in PRC regulations and rules, with 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
Job ID: 90293
Organisation: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time