Regulatory Expert - Wrocław
1 miesiąc temu
Job Summary
We are looking for a Regulatory Expert to ensure the regulatory compliance of our medical software. The candidate will be responsible for preparing regulatory documentation and maintaining the integrity of the Technical File and Design History File.- Preparing regulatory documentation in accordance with MDR/IVDR and FDA requirements.
- Maintaining and enhancing the QMS.
- Preparing documentation for safety risk management and cybersecurity management processes.
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