RA | 专业人力资源服务公司

1. Assist to prepare, submit the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner. 按照注册时限要求，在符合相应法规及公司内部SOP的前提下，协助进行注册文档的准备、递交及获批。 2. Make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements. 确保注册递交资料的真实性和准确性，按照公司要求保存注册相关资料及批准资料。 3. Assist QC testing per registration forecast plan. 依据公司产品上市计划协助产品注册检测。 4. Support the regulatory affair related work, including but not limited to payment, reagent order, achieving document management, warehouse management, etc. 支持法规事务相关工作，包括但不限于付款、试剂订购、存档文件管理、库房管理等。 5. Provide the cross cooperation with other departments. 跨部门合作。 6. Establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company. 建立并保持与政府部门及重点客户的良好关系，为公司提供有价值的意见。

Education& Qualifications教育背景与专业资格: 1. Bachelor degree or above, subject on medicine/bioengineering/clinical medicine/biochemistry or other related subjects. 大学本科以上学历，医学/生物工程/临床医学/生化或其他相关专业 2. Know medical device regulation. 了解医疗器械法规 3. Fluent English in listening, speaking, reading and writing. 英语流利，听说读写俱佳 4. Good skill on computer, MS-Office operation. 熟练操作MS-OFFICE软件 Experience工作经验: 1. Love regulatory work, with related work experience in medical regulatory affairs preferred. 热爱法规事务工作，有医学法规事务相关工作经验者优先。 2. High enthusiasm and devotion, work hard and earnest 具有强烈的事业心，工作仔细认真。 3. Willing to work under pressure, self-starting and self-inspiring 能承受高强度的工作压力，积极主动并自我激励。 4. Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration 为人诚实、开朗，善于与人沟通和合作，有较强的社会活动能力。 5. Innovating with good independent working ability 在工作中不断创新，能独立处理问题 6. Energetic team spirit 有团队合作精神

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职位要求