保存工作 返回搜索结果 职责描述 职位概要 类似职位 Be part of a pioneering team introducing a clinically validated technology. Take ownership of regulatory strategy for a novel Class II medical device. 关于我们的客户 This fast-growing medical device startup is advancing maternal health through a breakthrough diagnostic technology developed at the University of Sheffield, UK. The device is designed for hospital use to assess preterm birth risk with 55% higher accuracy than current market alternatives, as demonstrated in a 450-patient UK clinical study. With UAE registration nearly complete and UK underway, the company is now expanding into China and seeking a dedicated RAQA Manager to lead this effort. 职责描述 1.Develop and execute China regulatory strategy for Class II active medical device registration.2.Prepare and submit registration dossiers in accordance with NMPA requirements.3.Liaise with regulatory authorities, consultants, and testing labs to facilitate approvals.4.Establish and maintain quality management systems aligned with ISO 13485 and China GMP.5.Support post-market surveillance and compliance activities.6.Collaborate with global RAQA counterparts to align regulatory approaches. 理想的求职者 1.Bachelor's degree or above in biomedical engineering, life sciences, or related field.2.Minimum 5 years of RAQA experience in medical devices, ideally with Class II active products.3.Proven track record of successful NMPA submissions and product registrations.4.Familiarity with ISO 13485, China GMP, and relevant regulatory standards.5.Strong communication skills in both English and Chinese.6.Self-driven, detail-oriented, and comfortable working in a startup environment. 薪酬待遇 Competitive compensation package.Opportunity to shape the China market entry of a high-impact technology.Work with an international team committed to improving maternal health outcomes.Flexible working arrangements and a collaborative culture. 联系 Chris Qu 职位编号 JN-112025-6877973 联系电话 +86 21 6035 3502 职位概要 职位类别 生命科学 子类别 法规事务 行业 医疗保健/制药 地区 杭州市 工作类型 全职 顾问名字 Chris Qu 顾问电话号码 +86 21 6035 3502 职位编号 JN-112025-6877973
