Ayushi Banerjee

I am a Regulatory Affairs and Quality Assurance professional with a Master’s in Regulatory Science from the University of Southern California and hands-on experience ensuring compliance for medical devices. My academic background and practical experiences have fueled my passion for advancing healthcare solutions through robust regulatory practices and I am eager to leverage it to tackle complex challenges and support the development of safe and effective medical technologies. I have strong technical skills in regulatory compliance, including proficiency in FDA, ISO 15223-1:2021, and EU MDR regulations, ensuring adherence to quality and safety standards. My experience in document control involves managing and maintaining technical documentation effectively using systems like Laserfiche and Qualio. I am well-versed in risk management, performing root cause analyses, developing CAPA plans, and implementing corrective actions to address compliance issues. Additionally, I am familiar with ANSI/ASQ Z1.4 standards for quality inspections, applying these principles to conduct sampling and quality assessments in GMP environments. My analytical skills enable me to review reports, interpret regulations, and identify areas for process improvement efficiently. Let’s connect to discuss insights, innovations, and opportunities for collaboration in transforming healthcare through regulatory excellence!