法规注册工程师（双休）

技能：Skills 1、Rich experience in literature search in databases(Pubmed,Embase etc)are preferred; 2、Good knowledge of statical technics; 3、Good ability to search incidents and recalls from foreign websites such as FDA MAUDE; 4、Demonstrated in the active medical device regulatory standards and skillful in the standards with respect to the electrosurgical insturments. 职责范围： 1、Compile clinical evaluation file for product MDR registration;2、Update and Maintain the clinical evaluation documents for marketed product; 3、Perform Post market surveillance &PMCF file for marketed products.4、Search incidents in reportable websites products; 5、Update Regulatory and standards(FDA,Health Canada,EU,TGA)information every month.