长沙招聘

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come and join our global team as Sr. Regulation Specialist

· 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。

Your tasks and responsibilities:

Your qualifications and experience:

We are looking for more than 3 years import product registration experiments (successfully to registration import new product) that should be cover implement IVD reagent type testing, communication with oversea manufacture and communication with national authority.

R&D experience/ background will be preferable.

Experience in Chinese national standard formulation and IVD industry standard formulation。

At least 6 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

Our global team:

Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture:

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

在西门子医疗，我们的目标是通过全面实现数字化医疗，助力医疗服务提供者在各自领域推进精准医疗、转化诊疗模式、改善患者体验，以全方位助力其提升价值。每一天，全球有五百万名患者在影像诊断、临床诊疗、实验室诊断、分子医学以及数字化医疗和企业服务方面受益于我们的创新技术和服务。拥有超过170年历史，在全球范围内持有18,000个专利，西门子医疗是领先的医疗技术公司。我们在全球超过70个国家约50,000名员工将继续创新，塑造医疗行业的未来。
At Siemens Healthineers, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare.
An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
We are a leading medical technology company with over 170 years of experience and 18,000 patents globally. With about 50,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.