Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Mission/Position Headline: This role will ensure clinical evaluation include clinical evaluation report, clinical study design and clinical study report successfully complete, compliance with the regulatory requirement. Areas of Responsibilities: 1. Provide NPI clinical registration strategy for China, participate the clinical plans development to be compliance with GCP, the regulation SOPs; 2. Participate the development of the clinical evaluation report across the product lines, review the CER to ensure it meet the requirement of CMDE; 3. Responsible for the CER supplemental request, including the document writing and communication with reviewers； 4. Work closely with investigator and product experts to develop clinical study documents, including protocol, investigator brochure, clinical study report etc., in compliance with regulations of China. 5. Proactively address possible risks for intended use, clinical evidence for regulatory submission and effective communication of risks if applicable 6. Participant the clinical relevant SOPs improvement. 7. Consistent and effective communication to all internal and external stakeholders; 8. Lead the clinical study for registration as needed, ensure the operation activities comply with GCP. Experience - At least 3 years experience in clinical trial or clinical affair for medical devices. - At least 1 years’ experience in development of CER and/or clinical protocol and/or CSR - Experience of project management for clinical trial, familiar with the operation of clinical trial. Education Master degree or above relevant in Clinical/Medical/ Biomedical engineering. Organization: Siemens Healthineers Company: Siemens Healthineers Ltd. Experience Level: Experienced Professional Full / Part time: Full-time