Job summary
Job category | Technical (Sales / Design / Development / Production Control)/Development / Research / Experimentation / Project Manager |
---|---|
Industry | Health Care/ Medical Equipment |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
English (Business) Japanese (Fluent) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
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
About interview
Liaison
RA/QA Staff
RGF HR Agent
500 〜 700 ten thousand JPY