Sudharsan Sathyamurthy

Strategic Leadership in Quality & Regulatory Affairs Regulatory Strategy & Global Compliance - Developed and executed global regulatory strategies across the product lifecycle—from new product development to market expansion and registration maintenance. - Ensured compliance with key international standards and regulations, including US FDA, EU IVDR, ISO 9001, and ISO 13485. - Proactively monitored regulatory changes, assessed business impact, and implemented adaptive compliance strategies. - Served as primary liaison for regulatory agency interactions, including vigilance reporting and field actions. - Acted as or appointed Person Responsible for Regulatory Compliance (PRRC) under EU IVDR, ensuring oversight and execution of mandated responsibilities. Quality Assurance & Risk Management - Applied Quality Management System (QMS) principles—especially Design Controls—to maintain compliance and enable competitive advantage. - Oversaw Risk Management activities, ensuring alignment with BEC procedures and international standards; appointed Site Risk Managers to reinforce local accountability. Cross-Functional Leadership & Strategic Collaboration - Partnered with R&D, Product Management, Clinical, and Manufacturing teams to align regulatory and quality strategies with business objectives. - Led regulatory agency engagements, including submissions, audits, and approvals, ensuring timely and successful outcomes. - Provided strategic counsel to executive leadership on regulatory and quality matters, influencing key decisions and risk mitigation strategies. Process Optimization & Continuous Improvement - Leveraged Policy Deployment to drive breakthrough solutions and strategic alignment. - Championed Danaher Business System (DBS), leading kaizen initiatives and process improvements to enhance operational efficiency. - Instituted best practices for regulatory submissions and quality assurance, fostering a culture of compliance, innovation, and continuous improvement.

- Strategic Quality & Regulatory Leadership Developed and executed comprehensive Quality and Regulatory strategies, ensuring full compliance and driving product excellence across the Flow Cytometry portfolio. - Accelerated New Product Development Partnered with R&D leadership to optimize NPD processes, resulting in a significant reduction in time-to-market and enhanced cross-functional alignment. - Regulatory Excellence & Speed Led targeted regulatory initiatives across multiple domains, achieving two 510(k) clearances in 2023—both within 90 days and with zero Additional Information Requests (AIRs). - Enhanced Regulatory Intelligence & Governance Strengthened global compliance by improving regulatory intelligence frameworks and governance processes, enabling proactive adaptation to evolving regulations. - Talent Development & Succession Planning Rolled out a structured Talent Assessment process, cultivating a robust talent pipeline and ensuring leadership continuity across the Quality and Regulatory teams.

- Site Head of Quality and Regulatory and Management Representative for Beckman Coulter Bangalore Development - Responsible for Quality of products and processes, Product registrations and Regulatory Compliance

- Led New Product Development activities for Research and In Vitro Diagnostic use - Led Fast Impact Team responsible for Post launch Product support, Design Support to Custom Reagents business, Complaint Handling and Quality improvements

* Research on host-pathogen interactions in meningococcal infection * Writing manuscripts * Presentation at seminars and conferences * Supervision of under-graduate and Masters students

Involved in research on immunomodulatory activity of herbal extracts. Studied the effects of medicinal plants on TNF-alpha secretion in mouse models of stress and arthritis using flow cytometry.

Dissertation titled "Role of Gly1, a secreted neisserial protein in meningococcal pathogenesis".