Project Manager (Clinical) – Registration
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- Understand laws and regulations of medical devices of global registration. Responsible for the quality control and management of clinical evaluation testing of each projects in global registration.
- Responsible for the design of clinical evaluation testing plan, follow up the progress of clinical test, and ensure that the clinical evaluation is carried out in strict accordance with the protocol, SOP and relevant regulations in international registration (e.g., ISO13485:2016, FDA QSR and EU MDR).
- Responsible for clinical evaluation test results collection, statistical analysis, summary and writing of clinical evaluation testing report.
- Work under Quality Assurance / Regulatory Affairs Department to understand international quality standards (ISO13485:2016, FDA QSR and EU MDR), standardize and implement SOP. Responsible for organizing, planning and writing SOP manual /WI/ Form and other technical documents.
- Work closely with machine learning team and product research and development team to understand product core technology, product functions and solutions. Responsible for writing technical documents for international product registration.
- Bachelor degree or above in clinical medicine or pharmacy, Minimum Master/PhD and above in Engineering or Science.
- Strongly recommended for at least 3 years of experience, knowledge, ability, and quality as a Clinical Research Associate (CRA).
- Good scientific awareness and experience in writing technical and research papers.
- Good mathematical and Bio-statistical background, familiar with Python and other programming languages, able to write code to analyze statistical results will additional.
- Proficient in English, excellent organizational and communication skills, good communication skills in both Chinese and English, able to communicate and write clearly and concisely in English.
- Careful and responsible, patient and meticulous, logical, team spirit, strong dedication and sense of responsibility.