Responsibilities
1. Be responsible for searching for and screening the clinical data of the subject device and the predicate device, including clinical literature, clinical trial data, and clinical experience data.
2. Be responsible for writing medical device CERs and its related attachments.
3. Be responsible for collecting the clinical literature and clinical trial information of the competitive products and the company products biweekly.
4. Be responsible for communicating with the vender to handle CER related translations events.
5. Be responsible for IIS study related PO events.
6. Be responsible for other assigned affairs.
任职要求
Requirements
1. Master’s degree or higher in clinical medicine, biomedical engineering, or a related field.
2. Minimum of 3 years of clinical experience or relevant industry experience in medical devices.
3. Proven expertise in medical devices clinical evaluation is mandatory. Have ever handled at least 1-2 medical device CER projects independently.
4. Proficient in English, excellent in reading and writing, good in listening and speaking.
5. Proficient in professional office software, including Word, Excel, and PowerPoint.