Mostafa Mouawie

I am a medical doctor and biomedical engineer with experience in Medtech and hospital environments, where I bridge clinical insights with product and regulatory perspectives. I focus on translating medical data or requirements into actionable solutions that work for end users.

In my current role as a Quality and Regulatory Affairs Specialist, I support risk identification and assessment activities and adapt how I communicate technical and medical information for different audiences, including engineering, clinical, regulatory, and management. I contribute to continuous improvement initiatives and structured problem-solving in a highly regulated medtech environment.

I prepare FDA regulatory interactions, including documentation, cross-functional coordination, and Pre-submissions. I bring strong collaboration habits from multidisciplinary settings, ensuring alignment across clinical, technical, and regulatory functions.

Previously, as a Radiology Resident, Medical Consultant, and Scientific Research Intern, I strengthened my ability to present results clearly, coordinate tasks in fast-paced environments, and turn complex information into deliverables tailored to diverse end users. I’m motivated by roles where effective communication and rigorous quality/regulatory thinking directly improve medical outcomes.