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
