国际临床工程师

岗位职责:
1. Conduct site selection and establish partnerships with domestic and international clinical trial centers. Utilize expertise in global clinical regulations to develop, organize, and monitor clinical trial protocols. Ensure high-quality execution of clinical projects per established project plans, timelines, and study protocols.
2. Oversee clinical project monitoring and quality control. Coordinate the implementation of international/domestic clinical trials to ensure strict compliance with applicable regulations, trial protocols, and company SOPs. Manage clinical study report preparation, review, clinical meetings, and trial documentation filings.
3. Collect and maintain up-to-date knowledge of clinical trial regulations, guidelines, and standards across various jurisdictions. Interpret regulatory requirements and conduct training sessions.
任职资格:
1. Bachelor’s degree or higher.
2. Major in Medical Devices, Clinical Medicine, Statistics, Software Engineering, or related field.
3. Proficiency in English as a working language; strong communication and interpersonal skills; foundational project management capabilities.
4. Commitment to learning regulations for medical devices and in vitro diagnostic (IVD) reagents, product standards/guidelines, device/IVD product technology/R&D principles, statistics, and medical sciences.