Sample interview questions: Can you describe any experience you have with regulatory and compliance requirements for medical devices?
Sample answer:
- Experience in conducting risk assessments and developing risk management plans for medical devices, in accordance with ISO 14971 and FDA regulations.
- Familiarity with regulatory requirements for medical devices, including FDA 21 CFR Part 820, ISO 13485, and EU MDR.
- Experience in preparing and submitting regulatory documentation, including design dossiers, premarket notifications, and investigational device exemption (IDE) applications.
- Knowledge of quality systems and best practices for medical device manufacturing, including ISO 13485 and FDA QSR.
- Experience in conducting audits and inspections of medical device manufacturers and suppliers.
- Familiarity with post-market surveillance and adverse event reporting requirements for medical devices.
- Experience in working with regulatory agencies, such as the FDA and EU notified bodies.
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Source: https://hireabo.com/job/5_1_41/Biomedical%20Engineer