processes, and a proactive approach to evolving regulations (FDA MLMD guidance, EU AI Act, MDR, ISO/IEC standards).
Key Responsibilities
• Develop and implement global regulatory strategies for AI‑based medicaldevices and integrated software/hardware...
Working knowledge of ISO 11607-1 (Packaging for Terminally Sterilized MedicalDevices - Requirements for Materials, Sterile Barrier Systems and Packaging Systems).
• Working knowledge of ISO 11607-2 (Packaging for Terminally Sterilized MedicalDevices...
strategy to post-market management.
The ideal candidate will manage a regulatory team, develop regulatory strategies, and engage with international regulatory bodies to secure timely approvals and market access for innovative medicaldevices.
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