助理法规事务经理_RAC_北京 北京

月薪：

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 02-26 发布
  • 做五休二
  • 绩效奖金
  • 节日福利
  • 专业培训
  • 五险一金
  • 带薪年假

职位描述

Job DescriptionJob Title: RA Associate Manager Department: RACJob Location: BeijingReport to: DS RA leader Subordinate: None POSITION SUMMARY Working closely with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & projects reporting; related regulations & technical standards collection and dissemination; influencing the global related product line regulatory environment and contribute to DS registration strategy and the post market surveillance actively. KEY RESPONSIBILITIES 1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.2. Manages the regulatory review of labels, promotional materials, for products that are under his/her responsibilities.3. Ensures compliance with China regulatory requirements, including but not limited to change management.4. Interact with CFDA on registration requirements and monitor changes to requirements.5. Independently manages and provide regulatory guidance to multiple long-term projects under supervision. 6. Represents BD externally in long term project in RA fields under the instruction of manger.7. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of. 8. Actively contribute to the post market surveillance issues on related responsible product line SKILLS AND ABILITIES 1. Minimum 3 years working experience in medical device regulatory affairs, experience in IVD will be a plus2. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.3. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues. 4. Sense to think strategically, to detect the essence of complex or ambiguous issues, and report to manager. 5. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.6. Manages and monitors multiple complex and diverse short term and long-term projects with direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.DESIRABLE Bachelor or Master Degree in a technical discipline (bioengineering, microbiology, chemical, biology, pharmaceutical preferred). 职能类别： 药品注册 医疗器械注册 关键字： IVD 体外诊断 法规事务

联系方式

朝阳区建国路77号

公司信息

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit www.bd.com. BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD在保护患者和医护人员安全、强化医学研究和临床实验室建设领域为行业所瞩目。公司提供创新的解决方案，以帮助推进医学和基因组学研究、加强传染性疾病和癌症的诊断、改善药物管理、促进感染预防、为手术和介入治疗提供工具，支持糖尿病管理。BD与全球范围内的机构组织携手，共同应对最具挑战的全球健康问题。公司在逾50个国家拥有分支机构，员工超过40,000人，公司与客户及合作伙伴紧密协作，以帮助改善医疗结果，降低医疗护理成本，提升效率，保护患者和医护人员安全并增加医疗可及性。更多信息，敬请访问www.bd.com/China。

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