Kumari Savitha

About Kumari Savitha

A highly accomplished and detail-oriented Quality Assurance and Regulatory Affairs (QARA) professional with nearly 14 years of experience, including close to 8 years in the medical device industry, specializing in Software as a Medical Device (SaMD) and AI-enabled medical devices. Proven expertise in developing and executing global compliance strategies, leading cross-functional teams, and driving regulatory excellence in alignment with standards such as ISO 13485:2016, ISO 14971:2019, IEC 62304:2006, FDA 21 CFR Part 820, and EU MDR.Demonstrated success in leading end-to-end project planning and execution across regulatory and quality initiatives, ensuring timely delivery of milestones and alignment with business objectives. Experienced in overseeing CAPA processes, complaint handling, and risk management to support continuous improvement. Highly skilled in reviewing regulatory documentation, collaborating with CROs, and ensuring clinical trial integrity.Adept at managing internal and external audits, establishing and maintaining QMS policies, and supporting regulatory submissions including 510(k), IND, and NDA filings. Strong background in cybersecurity compliance, with a focus on seamlessly integrating regulatory requirements throughout the product development lifecycle in collaboration with cross-functional teams.Recognized for building and mentoring high-performing quality teams, leading strategic planning efforts, and ensuring regulatory readiness while working closely with executive leadership. Passionate about blending compliance with innovation to drive efficiency, scalability, and excellence in the medical device industry.

Experience

1. Quality Management Engineer - Design Controls

   UnitedHealth Group

   Jun 2025 — Present

Education

• Sri Siddhartha Institute of Technology, Tumkur

  Bachelor of Engineering (BE), Computer Science

  2002 — 2006

• Ramaiah Institute Of Technology

  M.Tech, Software Engineering

  2006 — 2008