注册工程师

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Summary
概述：
This position will be responsible for completing SunTech Shenzhen’s products register and conduct to internal regulatory training to improve current quality activities. The engineer will work with other department team members to establish and maintain appropriate systems to ensure regulatory compliance consistent with CFDA, FDA, CE/MDD and other international or domestic laws. At the same time, the engineer will work in QA department and be responsible for communicate with SMI team on register and relevant regulatory issues.
该职位负责完成深圳顺泰公司的产品注册和内部法规培训提升当前的品质状况。该工程师和公司其他部门一起建立适当的、符合CFDA,FDA,CE指令和其他国际国内法规要求的产品注册体系。 同时该工程师属于质量部，负责和美国SMI工程师沟通解决注册和法规的问题。

Duties and Responsibilities
职责内容：
1. Provides customer support on register and regulatory issues.
给客户提供注册和法规方面的支持；
2. Manages technical aspects of quality issues and problems.
管理产品技术方面的质量问题；
3. Conduct to develop and maintain product technical construction files, Responsible for recognizing and collecting main regulations and medical devices technology standards world-wide, and imbue the regulations and standards at SMC to ensure the processes and products of Suntech meet related requirements.
主导开发和维护产品的技术文件；负责识别与收集世界各国医疗器械法律法规与技术标准，并且在公司内部进行宣导，确保顺泰公司的产品与过程符合法规的要求。
4. Responsible for medical device registration.
负责产品注册 。
5. Provides project leadership for needed updates to existing products caused by new/revised standards，support world-wide regulatory compliance of Suntech products and/or services, including RoHS, REACH, Risk management , IEC series standard, etc..
主导项目评审新修订标准对产品造成的影响并按需要进行更新，为顺泰的产品/服务满足世界范围内的法规要求提供支持，包括RoHS, REACH，风险管理，IEC系列标准，等等。
6. Work closely with other departments, especially Engineering, to ensure new products are in compliance with published standards
与其他部门，特别是工程部紧密合作，确保新产品满足新标准的要求。
7. Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc
新法规的和其他医疗器械相关的信息，会议的跟进。
8. Conduct training and/or communicate appropriate material to internal staff to aid in compliance, Assist in developing regulatory affairs internal policies and procedures, and provide compliance training.
主导内部员工合规性培训/交流；协助制定内部政策和流程，并提供合规性培训。
9. Other duties as assigned.
其他安排的事项。


Education:
教育程度:
Bachelor degree or above.
大学本科或以上学历

Language:
语言要求:
Proficient in English both oral and written.
熟练英文口语和写作。

Experience:
工作经验:
1. Above 5 years’ working experience in medical device register/ include FDA 510k and CE, CFDA register.
5年以上产品注册经验/包括FDA 510K, CE和国内注册经验。
2. Minimum 2 years experience in medical devices company work experience.
至少2年以上的医疗器械公司工作经验。

Key attributes:
能力要求:
1. Be familiar with ISO9001:2008 and ISO13485:2003, QSR820 quality standard, and have applied
experience with them; or FDA or CFDA is preferred.
熟悉ISO-9001,ISO13485和QSR820质量管理体系，并有一定的应用经验，有FDA or CFDA经验者优先。
2. Familiar with CFDA or FDA registration procedure and regulations.
熟悉中国CFDA与美国注册流程和法规要求。
3. Familiar with medical devices technology standard ,such as : IEC60601, IEC80601,GB9701.-2007, etc..standard
了解医疗器械技术相关标准，如IEC系列标准和GB9701.-2007标准等。