The U.S. based medical device company

【Summary】
Collect the safety information regarding COMPANY’s products from Japan and overseas, and conduct investigation, analysis, evaluation. Responsible for safety management activities and implement appropriate measures. Conduct appropriate safety management activities in cooperation with overseas manufacturers and related departments, and improve internal/external customer satisfaction. Collaborate with PMDA Safety Division and other agencies for such PMS activities.

【Major responsibilities】
- Receive product complaints and report them to overseas manufacturers.
-Attend team and related departments meeting and discuss about the complaints
-Create a customer letter and communicate with Sales rep to respond to customers
-Confirm the investigation result and obtain the root cause information, NC and/or CAPA from the manufacturers
-Maintaining customer complaint files and complaint data
-Submission of the PMDA report regarding adverse event occurred in Japan and overseas
-Conduct GVP training to Sales rep
-Revise the work instruction regarding GVP if necessary
-Revision of Japanese package insert
-Collets safety information from medical presentations and medical literatures

【Requirements】
-Over 3 years experiences of GVP in QA function at medical device industry.
-Knowledge of Japanese PMD Act (including GVP and QMS)
-Knowledge and experience of ISO 13485 is a plus
-Intermediate or higher level of English