职位描述
职位描述：
PART I - POSITION SUMMARY 职位概要
Mainly engaged in registration for imported medical devices (including registration product standards, product inspection, register data preparation and filing), to make sure the progress of application.
主要从事进口医疗器械产品注册的相关工作（涉及注册产品标准、产品检测、产品注册资料的准备及整理），确保产品申报的进度。
PART II - PRINCIPAL RESPONSIBILITIES 主要职责
1. With manager or other people’s help, be responsible for the local registration of medical device products, to ensure registration is processed as plan, including:
在经理或其他人的帮助下，负责公司医疗器械产品在国内的注册，确保产品的注册进程按照计划进行, 包括：
（1） Coordinate with Marketing, Sales and Global RA, to work out registration plan.
与市场部，销售部，国际注册部进行协调，制定注册计划
（2）According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.
按照相关法律法规及标准的要求，起草产品技术要求(根据产品)，跟进产品检测；与检验、测试机构保持密切联系，建立良好关系，确保注册检验的顺利进行
（3）Communication with CFDA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.
与国家药监局等部门联系沟通，确保各个注册申请的报送、技术审评和审批的顺利进行，实时跟踪产品注册进程，确保按时获证
（4）To make necessary change, correction, IFU-Updating after getting the registration certificate.
取得注册证书后,如需要,根据实际情况,进行注册证书的变更、纠错、说明书备案的工作
2. Study and understand local/international regulation, provide basic suggestion on registration or certification.
负责研究和了解国内国际的法律法规，为产品注册或认证提供基本的咨询建议
3. Maintain registration documents in order, file the product data.
有序管理产品的注册资料文档，负责产品的资料归档
4. To make the Chinese label and IFU according to CFDA’s requirements with manager or other people’s guide
在经理或其他人的指导下，根据CFDA的要求，制作产品的中文标签和说明书
5. Provide related document to Commercial, Sales department.
提供公司商务、销售部门招投标需要的有关法规文件。
PART III – QUALIFICATIONS 任职要求
EDUCATION 教育程度
Bachelor degree or above, major in Medical, Medical device, Biomedical Engineering, Electro-mechanics, Materials is preferred
大学本科及以上学历，医学，医疗器械、生物医学工程、机电、材料等专业优先；
EXPERIENCE 工作经验
1. At least 2 years experience in registration.
至少有2年产品注册经验。
2. Familiar with local medical device registration process, regulations and standards.
熟悉国内医疗器械产品注册流程、行业法规规定及标准
3. Proficient in the use of MS Office suite.
能够熟练操作常用办公软件。
OTHER QUALIFICATIONS (Physical, Visual etc.) 其他要求
1. common communication in Chinese and English
有通常水平的中英文沟通能力
2. Carefulness, preciseness, initiative and strong rationality, strong sense of responsibility and team work
工作作风细致、严谨、主动、条理性强，有高度的责任感和良好的团队合作精神
