Save Job Back to Search Job Description Summary Similar Jobs Be part of a pioneering team introducing a clinically validated technology. Take ownership of regulatory strategy for a novel Class II medical device. About Our Client 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. Job Description 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. The Successful Applicant 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. What's on Offer 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. Contact Chris Qu Quote job ref JN-112025-6877973 Phone number +86 21 6035 3502 Job summary Function Life Sciences Specialisation Regulatory Affairs What is your area of specialisation? Healthcare / Pharmaceutical Location Hangzhou Contract type Permanent Consultant name Chris Qu Consultant phone +86 21 6035 3502 Job Reference JN-112025-6877973
