FDA Consultant
- Джерело:
- djinni.co
Що робити
- Advise the team on FDA submission requirements and documentation structure.
- Review and guide the preparation of FDA-related QA documentation.
- Help define what documents are required and how they should be prepared.
- Mentor the QA specialist on correct documentation format and process.
- Review documentation drafts and provide practical feedback.
Що пропонуємо
- Experience with FDA 510(k) submission.
- Experience with QA documentation for medical device software.
- Experience mentoring QA engineers.
- Experience working with startups or small product teams.
- Knowledge of traceability matrices, test documentation, validation documentation, risk-based testing, STP / STD / STR / ATP.
Схожі вакансії
З блогу Trackr
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