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
语言要求：
英语
Responsibilities:
1.? 完成医疗器械注册、再注册及补充申请资料的整理及申报。
Be responsible for documentation preparing of medical device registration, re-registration and additional information supplement.
2.? 完成医疗器械审批、技术复核等相关沟通工作，跟踪项目申报进度，解决申报过程中遇到的问题。
Be responsible for communicating of medical device registration, technology review, follow the progress of registration and solve the problems during registration.
3.? 负责相关体系文件的编制。
Be responsible for establishing relative system documents.
4.? 按计划完成公司内审和巡视审核并负责跟踪内审和巡视审核不符合项整改。
Conduct internal audit and walk through assessment and follow up nonconformities arise from internal audit and walk through assessment.
5.? 纠正预防措施的跟踪、归档。
Following up filing corrective and preventive actions.
6.? 负责完成法规部经理指派的临时工作。
Be responsible for finishing other jobs assigned by RC Manager.
Requirements:
1.? 大专以上学历。
College degree or above.
2.? 有医疗器械申报注册相关工作经验。
Have experience of medical device registration.
3.? 熟悉国家医疗器械注册的相关法规、条例及注册流程，能够独立完成申报的撰写、审核、整 理、上报资料的工作，并跟踪注册进程。
Familiar with applicable SFDA Medical Device Regulations and register process. Develop, review and prepare registration document independently, follow the progress of registration.
4.? 熟悉ISO9001或ISO13485质量管理体系。
More than one year’s working experience of QA or RC quality management, be familiar with ISO 9001 or ISO 13485 quality management system.
5.? 良好的英语听、说、读、写能力。
A good command of English in listening, speaking, reading and writing.
6.? 耐心、细心，有责任心，有良好的沟通能力。
Be patient, circumspect and conscientious, good communication skill.
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
