Senior Regulatory Affairs Specialist

博士伦隶属于博士伦公司（纽约证券交易所代码：BLCO）（多伦多证券交易所代码：BHC），是中国最知名和最受尊敬的医疗保健公司之一。我们为客户提供最全面和最优质的眼科保健产品，包括隐形眼镜和镜片护理产品，药品，人工晶状体和其他眼科手术产品，以及医学美容产品。我们的首要任务是为我们所服务的人群创造福祉。通过倾听客户和患者的心声，通过不断磨练我们的创新优势，通过诚信和卓越的执行，我们努力赢得我们的合作伙伴和利益相关者的信任。

1. Be familiar with and implement relevant Chinese laws, regulations, rules, specifications, mandatory standards and product technical requirements with the guide from manager, perform job responsibilities, ensure registration compliance, and take responsibility for the job

在经理的指导下，熟知并贯彻中国相关法律、法规、规章、规范、强制性标准和产品技术要求，履行岗位职责，确保注册工作合规、并对本岗位工作承担责任；

2. Be responsible for the registration of local and imported contact lens products with the guideline from manager, to ensure registration is processed as plan, including:

在经理的指导下，负责公司接触镜产品在国内的注册，确保产品的注册进程按照计划进行, 包括：

A. Coordinate with Marketing, Sales, Clinical Team and Global departments, to gather registration documents.

与市场部，销售部，临床团队和国际部门进行协调，收集注册文件

B. According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.

按照相关法律法规及标准的要求，起草产品技术要求(根据产品)，跟进产品检测；与检验、测试机构保持密切联系，建立良好关系，确保注册检验的顺利进行

C. Communication with NMPA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.

与国家药监局等部门联系沟通，确保各个注册申请的报送、技术审评和审批的顺利进行，实时跟踪产品注册进程，确保按时获证

D. To make necessary variation, correction, IFU-Updating after getting the registration certificate.

取得注册证书后,如需要,根据实际情况,进行注册证书的变更、纠错、说明书备案的工作

3. Learn and understand local/international regulation, conduct registration work and provide basic suggestions based on changed regulations.

研究和了解国内国际的法律法规，根据变化的法规进行产品注册并提供基本建议

4. Review the Chinese label and IFU according to NMPA’s requirements with manager.

根据NMPA的要求，和经理审核产品的中文标签和说明书

5. Provide related document to Commercial, Sales, Supply Chain, IT departments, etc. Update product registration information in the internal system.

提供公司商务、销售、供应链、IT等部门需要的有关法规文件。在内部系统中更新产品注册证信息

此职位可在以下工作地点：CN - Beijing 1
博士伦致力于利用多元化员工的才能为我们的业务和员工创造良好的机会。所有合格的申请人都将获得就业考虑，不论其种族，肤色，宗教，性别，性取向，性别认同，国籍，残疾或退伍军人身份。