Darius Daruwala

Ivdr Lead, Global Regulatory and Clinical Affairs at Siemens Point of Care @Siemens Healthineers

New York, NY, US

Manage submission of Technical Files/design dossiers for CE marking. Negotiate and interact with EU notified body during the development and review processes to ensure submission approval/clearance. Establish regulatory objectives; interact with multiple department heads for inter-functional tradeoffs; manage program budget and risks; develop and establish regulatory KPIs; manage timely updates to all stakeholders; and present progress to steering committee. Create and maintain Regulatory submission timelines and ensure that they are functional, consistent, and adequately supported. Integrate cross-functional dependencies from R&D, QA, Marketing, Operations, Labeling, Medical and Clinical Affairs to ensure regulatory requirements are properly covered and implemented. Department representative for impact assessment, risk classification and post-market compliance per EU IVDR. Analyze internal Regulatory Affairs processes, identify opportunities for improvements, develop and integrate Project Management methodologies and actively contribute at monthly Regulatory Sub-team meetings. Participate in advocacy groups like AdvaMed and MedTech to understand and influence emerging new and revised regulatory requirements.

Marquette University

BS

Milwaukee School of Engineering

Master of Business Administration (MBA)