Regulatory Affairs Supervisor/Manager
帝肯（上海）贸易有限公司
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2017-10-30
- 工作地点：北京
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：8000+ /月
- 职位类别：医疗器械注册 政府事务管理
职位描述
职位描述：
MAIN RESPONSIBILITIES:
1. Preparing, coordinating, translating and submitting regulatory applications to health authority. Ensure product registrations are reviewed and renewed as required. Contribute to global regulatory submission planning.
2. Prioritize and plan on product registrations within his/her area of responsibility to meet Chinese business requirements.
3. Maintain and actively manage pending applications through the testing and approval process.
4. Respond to regulatory agency questions within minimum timeline and in appropriate quality.
5. Establish and maintain a good working relationship with HQ RA peers & local management, and make full use of company information source system (SAP) to gain positive & timely support for document preparation and any questions raised by HA.
6. Monitor and support registration agent as applicable for projects /products of his/her area of responsibility.
7. Provide the management teams with regular updates on product registration.
8. Interact with the health authorities in appropriate way by using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
9. Support local regulatory strategies for company projects and closely work/provide advice on RA matters to the marketing team.
10. Undertake other RA responsibilities upon assigned products, i.e. adverse event reporting, promotion material review.
11. Provide input to regulatory function development plans for projects /products of his/her area of responsibility.
12. Actively contribute to RA trainings provided to local organization.
JOB REQUIREMENTS:
1. Bachelor's degree in medicine, pharmacy, and biological scientific or related discipline, related preferred.
2. At least 3-5 years working experience in the field of medical device regulatory affairs, both IVD reagent and active medical device related preferred. Experience in local clinical trial would be an advantage.
3. Experience and knowledge of regulatory affairs, regulatory compliance and quality systems in medical device industry and experience in working with government officials (e.g.CFDA or testing laboratories).
4. Ability to prioritize, plan & evaluate deliverables.
5. Good communication skill in Chinese and English, including written and verbal. Good computer skills in Microsoft office.
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MAIN RESPONSIBILITIES:
1. Preparing, coordinating, translating and submitting regulatory applications to health authority. Ensure product registrations are reviewed and renewed as required. Contribute to global regulatory submission planning.
2. Prioritize and plan on product registrations within his/her area of responsibility to meet Chinese business requirements.
3. Maintain and actively manage pending applications through the testing and approval process.
4. Respond to regulatory agency questions within minimum timeline and in appropriate quality.
5. Establish and maintain a good working relationship with HQ RA peers & local management, and make full use of company information source system (SAP) to gain positive & timely support for document preparation and any questions raised by HA.
6. Monitor and support registration agent as applicable for projects /products of his/her area of responsibility.
7. Provide the management teams with regular updates on product registration.
8. Interact with the health authorities in appropriate way by using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
9. Support local regulatory strategies for company projects and closely work/provide advice on RA matters to the marketing team.
10. Undertake other RA responsibilities upon assigned products, i.e. adverse event reporting, promotion material review.
11. Provide input to regulatory function development plans for projects /products of his/her area of responsibility.
12. Actively contribute to RA trainings provided to local organization.
JOB REQUIREMENTS:
1. Bachelor's degree in medicine, pharmacy, and biological scientific or related discipline, related preferred.
2. At least 3-5 years working experience in the field of medical device regulatory affairs, both IVD reagent and active medical device related preferred. Experience in local clinical trial would be an advantage.
3. Experience and knowledge of regulatory affairs, regulatory compliance and quality systems in medical device industry and experience in working with government officials (e.g.CFDA or testing laboratories).
4. Ability to prioritize, plan & evaluate deliverables.
5. Good communication skill in Chinese and English, including written and verbal. Good computer skills in Microsoft office.
职能类别： 医疗器械注册 政府事务管理
公司介绍
Tecan 是一家全球领先的自动化实验室设备和解决方案供应商。我们的系统和元部件可以帮助从事临床诊断、基础与转化研究以及药物研发人员，将他们的科学成果转为现实。
值得一提的是，我们自主研发，生产，销售并为自动化工作流程解决方案提供技术支持，而这将可以使实验室取得更多的科研成果。我们的Cavro元部件是多个学科具有领先地位的仪器供应商们的共同选择。
我们与广大客户并肩合作，包括诊断实验室、制药和生物技术公司以及大学研究中心等等。我们专注于研发和生产OEM设备和元部件，并由我们的合作伙伴进行市场上的销售工作。无论客户项目是大还是小，简单亦或复杂——帮助他们达成目标始终是***位的。
我们几乎在所有专注的领域均有极强的竞争力，而这已经改变了世界各地科研实验室的工作方式。 例如，在诊断行业，我们在测试的可重复性和吞吐量方面提高了业界标准。
在不到四十年的时间里，Tecan便从一家瑞士家族企业成长为一个已经立足于全球生命科学舞台的品牌。从初期农场的拓荒时代到如今处于业界前列-我们正在为世界各地的科研、诊断工作和诸多应用市场注入能量。
帝肯中国网站： *********************
值得一提的是，我们自主研发，生产，销售并为自动化工作流程解决方案提供技术支持，而这将可以使实验室取得更多的科研成果。我们的Cavro元部件是多个学科具有领先地位的仪器供应商们的共同选择。
我们与广大客户并肩合作，包括诊断实验室、制药和生物技术公司以及大学研究中心等等。我们专注于研发和生产OEM设备和元部件，并由我们的合作伙伴进行市场上的销售工作。无论客户项目是大还是小，简单亦或复杂——帮助他们达成目标始终是***位的。
我们几乎在所有专注的领域均有极强的竞争力，而这已经改变了世界各地科研实验室的工作方式。 例如，在诊断行业，我们在测试的可重复性和吞吐量方面提高了业界标准。
在不到四十年的时间里，Tecan便从一家瑞士家族企业成长为一个已经立足于全球生命科学舞台的品牌。从初期农场的拓荒时代到如今处于业界前列-我们正在为世界各地的科研、诊断工作和诸多应用市场注入能量。
帝肯中国网站： *********************
联系方式
- 公司地址：北京经济技术开发区荣华中路19号朝林广场B楼1903A-1903B