高级法规事务规范专员_RA&C_上海 上海

月薪：

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 12-01 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 定期体检
  • 专业培训
  • 通讯补贴
  • 年终奖金

职位描述

职位描述： Job Description岗位描述Job Title职位: Sr. Specialist or Associate Manager, Regulatory Compliance 高级专员或助理经理，法规事务合规Department部门: Regulatory Affairs and Compliance法规事务及规范部Job Location工作地点: Shanghai, P.R. China中国，上海Report to汇报给: Sr. Regulatory Compliance Manager 高级法规事务经理Subordinate从属 : n/aPOSITION SUMMARY职位综述This position is to translate post-market regulatory requirements into China working process; to play an active role to communicate with internal/external customers to ensure proper implementation of procedures in consistent with regulation.该职位将致力于从法规合规经营的角度将后市场法规要求融入公司日常工作流程中，积极与内外部客户互动交流，确保后市场工作流程合理实施，从而符合公司流程和法规要求。KEY RESPONSIBILITIES主要职责1.Follow the current procedures of regulatory compliance, such as recall reporting/AER/Promotional material review and approval etc. and find opportunities to improve the process根据现有法规合规工作流程执行日常工作，比如医疗器械召回管理流程、不良事件报告流程、文字材料审核批准流程等，并对流程进行适当改进2.Provide proper input at country level when receiving field action notification and keep communication when necessary收到区域行动信息时，及时提供中国的反馈并保持与总部的联系3.Upload China AER into global vigilance and download oversea AER for submitting in China based on CFDA regulation将中国发生的不良事件录入global vigilance系统并下载境外不良事件在中国进行上报4.Coordinate and submit the promotional materials for SHFDA/JSFDA approval when necessary需要时，协调并递交医疗器械文字材料，跟进上海市药监部门和江苏省药监部门进行审批流程5.Prepare SOP training materials and provide SOP training to the relevant peers and keep training records根据SOP制作相应的培训材料并对相关人员进行培训，保留培训记录6.Other assignments that may have其他可能的工作安排SKILLS AND ABILITIES技巧和能力1.Ability to work with minimal supervision. Ability to prioritize, & evaluate deliverables. Be a proactive thinker.具备独立工作的能力，对于所交付的工作按轻重缓急评估处理2.Demonstrated ability to interact externally with regulators and internally with WW BD associates.能够与公司外部监管部门及总部同事进行有效沟通和互动3.Dependability: team work, reliable, responsible, dedicated, committed and fulfilling obligations and detailed working attitude.可靠性：具有团队合作、值得信赖、负责、敬业、担当和细致的工作态度4.Excellent verbal and written communication skills both in Chinese and English.熟练的中英文沟通技巧5.Strong interpersonal skills, ambitious and aggressive personality, can work under pressure; problem solving oriented and willing to learn具备人际交往技巧、积极进取、能承受工作压力，以解决问题为导向工作并具有不断学习的意愿6.Minimum three to five years of directly related experience in medical device and drug packaging product fields with regulatory compliance knowledge至少3-5年药品、医疗器械、药包材行业等相关经历，并具有法规合规知识DESIRABLE满足条件B.S. or B.A. degree in a technical discipline (bioengineering, biology, microbiology, or molecular biology preferred).技术学科领域学士学位，如生物工程、生物学、微生物学或分子生物学优先 职能类别： 医疗器械注册 医疗器械生产/质量管理

联系方式

中国上海市延安中路1228号静安嘉里中心

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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