医疗器械注册

该职位来源于猎聘 Main Responsibilities 主要工作职能：

• 熟悉医疗器械法规，能够为国内和进口产品注册提供法规战略思路和建议Be familiar with the medical device regulations and able to provide regulatory strategic thinking and proposal for domestic and imported products
• 与国家药品监督管理局就注册要求进行沟通，并监控法规的变化Interact with NMPA on registration requirements and monitor changes to regulatory requirements
• 负责国家药品监督管理局注册，跟进型式检验、新注册、变更注册、延续手续Take the ownership of NMPA registrations, following up with type testing, new registration, change registration and renew procedure
• 协助研发团队及原产国，为提交注册（器械分类申请提交、注册提交等)做准备Coordinate with R&D team & sourcing company for the preparation of submission dossiers (device classification application submission, registration submission, etc.)
• 与CRO公司联络并跟进产品型式检验和注册Liaise with and monitor the CRO company on product type testing and registration
• 积极参与上市许可持有人项目，为团队提供法规指导Actively participate in the MAH project and provide regulatory guidance to the team
• 参与新产品在全球的注册支持，准备注册资料，支持除中国以外各国家地区的产品上市项目Prepare and submit registrations to support the global registrations to align with the global NPI product launch plans
• 支持成熟产品在各国家，地区的注册项目，包括新注册，变更更注册，延续注册。Support in existing products’ global market expansions, license change and renewals.评估产品变更在各地区的影响，跟进相关的注册变更活动，协助研发和工厂完成变更的顺利实施。Conduct RA assessments due to product design changes, coordinate and support in the regional registration activities. Proactively plan the registrations triggered by changes, work closely with R&D and Production to ensure smooth change implementation.
• 与其他团队成员合作，验证产品是否符合法规要求Collaborate with other team members to verify whether product meets regulatory requirements
• 确保法规活动的法律合规性Ensure regulatory compliance of regulatory activities
• 根据公司业务需要，该岗位员工的主管经理可以向其指派以上未列出的额外的暂时或经常性工作。Depending on the business needs of company, the supervisor of this position can give extra temporary or regular assignment to the staff, which is not included above.
• 该岗位员工须了解公司质量管理系统。The staff in this position should know the quality management system of the company.
• 该岗位员工须安全开展工作并遵循公司已建立的安全政策和安全程序。The staff in this position should work safely and follow security policies and security procedures established by the company.
• 该岗位员工须了解并遵循公司商业行为准则。The staff in this position should know and follow the business conduct of.

Requirements 录用要求：

• 医学、工程、理学或其他相关专业本科以上学历Bachelor or advanced degree in medical, engineering, science or other related fields
• 3年以上国家药品监督管理局注册经验More than 3 years hands on experience in NMPA registration
• 有源产品在中国注册经验者优先 Experience in registration for active products in China strongly preferred
• 了解国际医疗器械法规，有相关注册经验者优先 Knowledge of global medical device rules and regulations of e.g. EU, North America, Japan, etc. are preferred
• 与监管部门的良好沟通技巧Excellent communication skill with regulatory authority
• 在加快产品注册流程方面具有创造性Creative in accelerating the product registration process
• 能够承受工作压力，按时完成工作 Able to work under pressure to meet tight timeline
• 熟练的电脑操作技能Good PC skills
• 出色的人际交往能力Excellent interpersonal skills
• 良好的口头和书面英语能力Good in both verbal and written English