• Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304). • Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements. • Coordinate and document the development of system architecture that ensures scalability, reliability, and compliance with safety and performance standards. • Define and document system requirements, functional specifications, risk management strategies, and validation procedures. • Conduct risk assessments and manage risk mitigation activities related to system safety and performance. • Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD. • Oversee verification and validation testing, ensuring traceability from requirements to system performance. • Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance. • Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices. • Develop design control documentation, including system requirements, design reviews, and traceability matrices. • Support post-market surveillance activities, including software updates, patches, and enhancements.