医疗体系专家

该职位来源于猎聘 Regulatory Affairs SME 法规专家 Job Description

• Assist Quality Manager to ensure functional management and business management is aware of and understands the principles and expectations associated with the applicable regulations. 协助质量经理确保职能管理部门人员和业务管理部门人员了解和理解适用法规的原则和期望。
• Assist Quality Manager in acting as a facilitator to site management in the tandardization and simplification of the standards. 协助质量经理在标准化和简化标准方面作为公司管理的推动者。
• Assist Quality Manager in Performing and documenting comprehensive risk assessment relating to regulatory affairs. 协助质量经理执行并记录与法规事务相关的综合风险评估。
• Assist site manager to prepare packages for NMPA submission. 协助公司经理准备向中国药监局提交资料。
• Assist and support Quality Manager when necessary in the development creation and documentation of world class quality and business system improvements, as well as support for customer and /or ISO/FDA/NMPA escalations as needed. 必要时协助和支持质量经理开发创建和记录质量和业务体系改进，以及根据需要为客户和/或ISO/FDA/NMPA升级提供支持。
• Solicit ongoing feedback from business units for effectiveness of regulatory support. 征求业务部门的持续反馈，以提高法规支持的有效性。
• Assist to coordinate activities of medical initiatives as required and keep focused in times of crises. 根据需要协助协调医疗行业活动，并在危机时刻保持专注。
• Coach and mentor the site to deliver regulatory affairs excellence to internal and external customers. 指导和培训公司向内部和外部客户提供法规事务。
• Evaluates and schedules appropriate training programs and/or seminar for new/update regulation requirements. 对于新的/更新的法规要求，评估和安排适当的培训计划和/或讨论会。
• Coordinate existing and future plant wide Quality System Improvement and certification programs. 协调现有的和未来的工厂质量体系改进和认证计划。
• Maintain good communication and relations with government. 与政府部门保持良好的沟通和关系。
• Must follow RBA and site EHS requirements. 必须遵守RBA职责和工厂EHS要求。