AI/ML Integration: Identify, evaluate, and prioritize opportunities to leverage AI/ML for improving clinical value (e.g., predictive analytics, automated reporting, diagnostic assistance). * Regulatory Compliance: Partner with Regulatory Affairs to ensure all product features, especially those involving AI/ML, comply with relevant medical device regulations (e.g., CE Mark) and data privacy laws (e.g., GDPR). * Understanding of the unique regulatory and ethical challenges associated with AI/ML in a clinical setting (e.g., bias, transparency, explainability). * Familiarity with device regulatory standards and norms(e.g., MDR, ISO13485, IEC 62304, SaMD). * A technical degree (e.g., Computer Science, Engineering), preferably with an MBE (Master of Business Engineering).
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