法规经理 RA Manager

1. 负责统筹公司产品注册管理工作，协调对接研发、质量、运营等部门协同完成注册任务 ；

Be responsible for coordinating the company's product registration management, coordinating the docking of R&D, quality, operations and other departments to complete the registration task;

2. 制定注册计划，组织协调设计开发、生产、质量等部门完成注册送检样品的准备；

Formulate the registration plan, organize and coordinate the design and development, production, quality and other departments to complete the preparation of registered samples for inspection；

3. 管理各证书的有效时限，适时启动注册证/许可证的延续、注销、延续等；

Manage the validity period of each certificate, and timely start the renewal, cancellation and extension of the registration certificate/license;

4. 负责保持和市场监管局的良好沟通，确保注册评审及审批顺利进行，实时跟踪产品注册进程；

Be responsible for maintaining good communication with the Market Supervision Bureau, ensuring smooth registration review and approval, and tracking the product registration process in real time；

5. 为研发阶段的技术问题提供法律法规支持，配合研发工艺改进；

Provide legal and regulatory support for technical problems in the R&D stage, and cooperate with R&D process improvement；

6. 负责跟踪、收集国内外政策法规，及时汇总、分类、整理、归档监管部门出台的各项法规、文件、技术资料；建立国内外注册相关政策信息库，并及时更新、做好公司内部培训；

Be responsible for tracking and collecting domestic and foreign policies and regulations, and timely summarizing, classifying, sorting out and archiving various laws, regulations, documents and technical data issued by regulatory authorities; Establish a domestic and foreign registration related policy information base, and timely update and do a good job in the company's internal training；

7. 负责组织协调现场核查等相关工作；

Organize and coordinate the on-site inspection and other related jobs;

8. 关注和掌握产品研发技术及注册法律法规的最新动态；及时更新相关产品管理及注册等相关法规及技术指导原则，并能及时根据最新法规进行修正；

Pay attention to and master the latest trends of product R&D technology and registration laws and regulations; Update relevant regulations and technical guidelines on product management and registration in a timely manner, and revise them in accordance with the latest regulations;

9. 管理和审查与注册/认证相关的变更，需要时立即启动注册证/许可证变更、公告机构通知、网站上传信息更新等；

Manage and review the changes related to registration/certification, and immediately start the registration/license changes, notification of the notified body, website upload information updates, etc. when necessary；

11. 预测法规和产品符合性的风险并且提出警告, 上市后产品相关问题的处理和应对；

Foresee regulatory/product compliance risk and alarm，handling and response to problems related to products after marketing;

REQUIREMENTS

- University graduate in Electronic or Electric or Mechanical Engineering or related subjects

电子或电气或机械工程或其他相关专业大学毕业

- At least 8 years relevant experience in active medical device regulatory affairs experience, quality experience is plus

至少8年有源医疗器械法规工作经验，有质量经验优先考虑

- Must be familiar with active medical device registration process

必须熟悉有源医疗器械注册流程

- With solid management experience

有扎实的管理经验

- Must be familiar with the GMP standards, ISO13485, MDR, GB9706 and etc

熟悉GMP标准，ISO 13485, MDR, GB9706等

- Initiative and self-motivated

积极主动，自我激励