和相关部门一起收集,理解和组织实施外部和内部法规确保合规。
Ensure post market survilliance requirements meet.确保上市后监督报告管理要求满足。
Maitain Class II & III Medical Device Business License as per new requirements.根据需求维护第二类医疗器械经营备案凭证和第三类医疗器械经营许可证。
Support NMPA audit.协助NMPA检查。
Support internal and external audits.协助内外部审核。
CAPA implantation. Follow up the NC (finding) of audit/accessment, tracking the completion.CAPA实施。跟踪审核的不符合(发现),核查,直至关闭。
Other tasks assigned by management.其它上级交给的工作
Education / 教育背景
Bachelor or above with major in Medical equipment, Machanical, Electronics, Biology, Chemistry, Medicine, Pharmacy, Chemical industry, Computer Science.
Experience /经验
Familiar with related local regulations.
熟悉本地法规
3-5 years or more professional working experience in GSP & postmarket survilliance management of NMPA
3-5年或以上专业GSP 和上市后管理经验
Experience for NMPA inspection
市场监督管理局审核经验
Other skills /其他技能
Communicate effectively with co-workers, superiors sufficient to exchange or convey information.
能和同事、上司有效沟通以交流信息。
English language skills: Proficient in writing, reading, listening and speaking.
英文语音能力:写、读、听、说熟练
Good time management skill, set priorities and meet critical time deadlines.
良好的时间管理技巧,设定优先级并达成关键时间期限