| Position : QA/RA Manager | ||
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| Recruiter | 
Stoneman Corporation
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| Company Name | Company name is not publicly visible |
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| Updated | 2008-12-17 | |
| Job Type | Medical/Pharmaceutical/Bio - Other Administrative - Logistics/Materials & Purchase Control |
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| Industry | Medical Equipment | |
| Location | Tokyo | |
| Job Description | * Management of both Quality Assurance and Regulatory Affairs. * Quality control and quality assurance for medical devices. * Science and physics testing, and construction schedule control/compliant handling for quality assurance. * Acts as the primary liaison with regulatory agencies. * Conducts effective and timely regulatory intelligence and research. * Oversee the preparation and completion of regulatory submissions, including safety reports, annual reports, and routine amendments. * Liaise internally with members of functional departments. * Liaise externally with vendors, licensors and joint development collaborators. |
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| Company Info | Medical Equipments | |
| Working Hours | 9:00 - 18:00 | |
| Qualifications | * MS/MA degree in related discipline and five years of related experience; or PhD in related discipline and two years of related experience, or Equivalent combination of education and experience. * More than 5 years overall experience in Quality Assurance/ Quality Control and/or Regulatory Affairs in the medical devices/ equipments/ machines industry * Experience in writing scientific documents/ papers in Japanese and English. * Working knowledge of Japan and/or international regulatory requirements * Managing experience. * Basic knowledge of the Pharmaceutical Law. * Good communication and problem solving skills. |
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| English Level | Daily Conversation Level (TOEIC 475-730) | |
| Japanese Level | Native Level | |
| Salary | Depends on experience | |
| Other Salary Description | Social Insurance Commutation Allowance |
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| Holidays | Five-Days Workweek Paid Holidays Sick Leave |
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