- Update technical files including risk management
Min 1-2 exp in medical device background highly preferred.
- EU MDR exp is highly preferred, not must .
- Design validation, design verification / IQ/OQ/PQ and Gap remediation / risk management and protocol writing exp required
- Quality background supporting product development and validation would be ideal.
- Bachelors in any technical field. (Ideally biomedical / mechanical engineering)
EU MDR, IQ/OQ/PQ, Gap remediation, risk management, protocol writing