Summary:
Seeking a bilingual Japanese - English Translator with experience in medical devices to translate technical and regulatory documents accurately.
Key Responsibilities:
- Translate and proofread documents (IFUs, SOPs, regulatory filings)
- Handle PMDA/FDA/EU MDR documentation
- Ensure accuracy of medical and technical terminology
- Collaborate with QA, RA, and R&D teams
- Maintain glossaries and translation tools
Requirements:
- 4–10 years translation experience in medical devices/healthcare
- Fluent in Japanese & English (JLPT N2 preferred)
- Knowledge of medical terminology and regulations (PMDA, FDA, ISO 13485)