Passionate about directly impacting lives through my work, I bring 18 years of expertise in leading Medical Device Software Quality and regulatory teams for Class III and Class II medical devices. My focus on developing safe and effective medical devices has positively influenced thousands of patients. With added layers of complexity such as AI and cyber-security on completely software-based medical devices (SaMDs) and firmware-based devices, risk management plays a giant role in regulatory and organizational policies. My expertise lies in risk management-driven design and development, which is the key to building high-quality & and regulatory-compliant products (FDA, MDR).As AI integrates into healthcare, I look forward to creatively contributing to the field of Medical Device Quality. As a dedicated volunteer at Vibha.org (a 100% volunteer-driven organization), I lend a hand in educating underprivileged children. I have held several leadership positions during my 16 years of volunteering at Vibha. ★ 18 years of experience managing and leading multimillion-dollar, cross-functional, global projects within the medical device industry★ Medical Device Software Expert with extensive experience in Software Quality Management Systems and Risk Management★ Re-engineering process and scaling solutions using LEAN principles, mind mapping, and affordable technology★ Received the prestigious President's Volunteer Service Award in 2016, 2022 and 2023CORE COMPETENCIES: Risk Management, Quality Management, Software V&V, Regulatory Submissions ( FDA 510(k), MDR, ISO 13485, IEC 62304, 21 CFR PART 11, 21 CFR Part 820), SaMD and Firmware Regulatory Compliance, Project Management and Program Management, Design Thinking, Process Optimization, Change Management, Project Planning, Agile Methodology, Inclusive Leadership, Relationship Building, Visual Management Systems