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.
- 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.
- Master’s degree or above relevant in Clinical/Medical/ Biomedical engineering.
Organization: Siemens Healthineers
Company: Siemens Healthineers Ltd.
Experience Level: Experienced Professional
Job Type: Full-time