Regulatory functions:

- Continuous control of ongoing regulatory actions and regular reporting to GPAG

-负责公司相关产品的注册流程，并持续管理及跟进，并定期向GPAG报告更新。

- Active exchange with GPAG/HQ during the submission process and communication with CFDA

-在注册流程中积极与总部保持联系并跟进，并与CFDA保持沟通。

- Direct communication with CFDA

-与CFDA直接沟通。

- Translation of submission documents according GPAG/HQ templates (new submissions, re-certifications and changes)

-根据GPAG/总部模板翻译提交文件(包括新提交、重新认证和更改)

- Professional judgment with regard to reporting of changes

-专业判断并预测政策及市场变化

- Work out regulatory strategies for China

-制定中国的注册监管战略。

- Regulatory Intelligence for China and education of HQ in this regard

-负责中国相关注册机构和公司总部在这方面的教育及培训。

- Plan and realize product testing (evaluate Chinese testing centers, select and support the process).

-计划、管理产品在中国的相关测试注册工作(评估确认中国的测试中心，并提供支持)。

Clinical functions:

- Responsible for negotiation e.g with clinical trial centers (approved by the national authority)/principal investigator, national CRO, IRB, national authority

-负责与临床试验中心(由国家权威机构批准) /首席研究员，国家CRO, IRB，国家权威等相关人员的得沟通谈判工作

- Responsible for organizing the preclinical package (if needed for marketing authorization of new products)

-负责产品临床前组织及相关注册工作(包括可能的对新产品进行营销授权)

- Translation/education of investigators/study centers

-对于调查人员/研究中心的翻译/培训

- Organize the performance of clinical studies in China (Select Chinese CRO? and control the process during the study)

-组织中国临床研究的绩效(选择评估合作的CRO，研究过程中控制过程)

- Oversight of clinical monitoring

-监督临床监测

- Interact with GPAG/HQ clinical personnel (support of clinical study)

-与GPAG/HQ临床人员保持联系及沟通(临床研究的支持)

- Assist GPAG/HQ during internal audits and authority inspections in China as well during CFDA inspections in CH

-协助总部完成在中国的内部审计和权威检查，以及在CFDA相关检查。

- Release of marketing materials (control of claims)

-市场相关资料的权威公布及声明

任职要求：

工作经验：5年以上行业内注册领域工作经验

学历学位：本科以上学历

专业能力：熟悉医疗器械行业法律法规

语言能力：中英文熟练