珠海凯德诺医疗器械有限公司
医学经理
Skills
2 months ago
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Important information
Contract type:
Permanent
Location:
Wuhan, Hubei, China
Work mode:
Onsite
Published on:
10 September 2026
What they need
该职位来源于猎聘 岗位职责: 1.主导制定医疗器械产品临床策略(如适应症拓展、临床证据生成计划); 2.审核临床试验方案(上市前&上市后)、研究者手册、产品说明书医学部分等关键文件; 3.建立并维护核心专家(KOL)合作关系,统筹医学学术推广活动; 4.协调研发、市场等跨部门团队,确保医学信息传递一致性; 5.分析产品上市后临床数据及不良事件趋势,提出医学层面风险控制建议; 6.管理医学主管团队,制定工作目标及能力提升计划; 7.跟踪NMPA/FDA 等监管机构的临床评价法规,确保医学活动合规; 任职资格: 1.临床医学、生物医学工程等相关专业,硕士及以上学历,拥有GCP 证书,医师资格证优先; 2.精通医疗器械临床研究法规(GCP、临床评价指导原则)、产品临床应用逻辑; 3.5 年以上医疗器械医学事务经验,2 年以上团队管理经验; 4.主导过至少1个三类医疗器械的临床策略制定及学术推广; 5.熟练使用 PPT/Excel,具备强沟通协调能力及战略思维。
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