Remote SaMD Certification Specialist

19 set - Italia
Bsi

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist for SaMD to support EC Certification worldwide. Based remotely, you will lead technical file assessments, design examinations and unannounced audits to ensure regulatory compliance.

You will interpret international standards for software medical devices, apply risk management and FMEA concepts, and collaborate with product teams to advance certifications and market access globally.

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