RA/QA Staff

Location: Japan - Tokyo
Job Type: Permanent
Salary: 5000000 - 7000000 JPY
Job Function: Regulatory Affairs
Reference: JO-191203-206985
Industry: Life Sciences & Healthcare
Sub-Industry: Medical Devices

Company Overview

Global Medical Device Maker

Job Description

– Importing non-approved product sample for evaluation
– Submitting an application file for reimbursement acquisition and maintenance
– Scheduling and keeping timeline for both product registration and business license
– Preparing and keeping budget for both product registration and business license
– Reporting product registration status to related division

Requirements

• Class I, II, III MD regulatory submissions to obtain approval/notification in Japan
• Gap analyses of dossiers provide by overseas sites in comparison with Japanese regulations
• Communication with governmental bodies
• QMS for new application/PCA/periodical renewal
• New submission/Renewal of FMR