RA Manager – Beijing, China at Cordis

Chaoyang District, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

26 Mar, 26

Salary

0.0

Posted On

26 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Product Registration, Communication, Project Management, Regulatory Affairs, Cardiovascular Knowledge, Policy Monitoring, Change Assessment, Collaboration, Industry Meetings, MS Office Proficiency, Fluent English

Industry

Medical Equipment Manufacturing

Description

概述 About Cordis For more than 60 years, Cordis has been a worldwide leader in the development and manufacturing of interventional vascular technology, offering higher quality and less invasive experiences for people around the world. With a robust global footprint with operations in more than 60 countries, we empower you to do your best and unleash your full potential. Do you want to grow your career surrounded by a supportive team of subject matter experts? Then join us and let’s improve the wellbeing of millions, together. 关于Cordis People are the heart of our business We are teammates, not just employees. Empowered to act as owners, our teammates deliver excellence in service of our mission: to delight our customers. Cordis is both a place to fulfill your career aspirations and a bigger purpose. Each teammate contributes to the wellbeing of millions of patients who enjoy healthier and longer lives as a direct result. Diversity and inclusion are foundational to our values and successes. The richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately the lives of our patients. Job Summary 岗位概述： Provide support on a range of medical device and activities for Great China (including HongKong and Taiwan) which include product submissions, implement regulatory strategies, change assessments, commercial supports, and other responsibilities aligned with medical device regulation and business goals. Keep the good relationships with related authorization agencies. 为大中华区（包括香港和台湾）医疗器械的注册活动提供支持，包括产品注册提交，实施注册策略，变更评估，商业支持以及与医疗器械法规和业务目标相一致的其他职责。保持与相关政府机构的良好关系。职责 Essential Functions and Responsibilities 职责描述: Implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations. 执行注册策略和年度计划，以确保所有类型的产品注册在设定的时间计划内进行。 Author product submission dossier and correspondent letters to authorities. 撰写产品注册提交文件和给主管部门的信函。 Directly communicate with local authorities (Testing Lab, CMDE and NMPA) upon implementing regulatory strategies on submissions. 按照注册策略直接与主管机构（检测实验室，CMDE和NMPA）进行沟通。 Monitor regulation, policy and standard changes from government authorities that have an impact on related products. 关注政府部门对相关产品有影响的法规、政策和标准的变化。 Assess regulatory impacts on various product/process changes. 评估各种产品/工艺变更对注册的影响。 Collaborate with necessary internal/external source to proceed with assigned projects. 与必要的内部/外部资源合作完成指定的项目。 Attend related industry meetings to gather latest information and input necessary company opinions with internal cross functional alignment. 参加相关行业会议，收集最新信息，并提出与内部职能部门达成一致的公司意见。 Manage the RA projects for HongKong and Taiwan. 管理香港和台湾法规项目。 Perform other duties as needed. 根据需要履行其他职责。资质 Qualifications 任职资格： Education & Experience 教育及经历 Bachelor’s Degree or above in related field 相关专业本科及以上学历 5 years’ experience in medical device regulatory affairs, non-active medical device registration experience is a plus 5年以上医疗器械法规事务工作经验，有无源医疗器械注册经验者优先 Profound knowledge in cardiovascular industry is a plus 具有心血管行业丰富知识优先考虑 Skills技能: Comprehensive knowledge of current regulations and guidelines 全面了解现行法规和指导原则 Fluent in English reading, writing and oral communications 流利的英语阅读、写作和口语交流能力 Familiar with MS Office applications 熟悉Office办公软件 Strong project management skills 较强的项目管理能力 Ability to adapt constant changes in fast pace 能够较快适应变化

Responsibilities

The RA Manager will implement regulatory strategies and manage product registrations for medical devices in Greater China. They will also maintain relationships with regulatory authorities and monitor changes in regulations that impact products.