Regulatory Affairs Graduate Student
Northeastern University
Afrah Mujeeb is a Master of Science in Regulatory Affairs candidate at Northeastern University with professional experience spanning regulatory affairs, quality, and manufacturing in the medical device and pharmaceutical sectors. She has supported U.S. FDA submissions, including 510(k) and eSTAR dossiers, contributed to clinical and postmarket documentation, and collaborated on regulatory strategy and compliance initiatives. Her work integrates knowledge of global regulatory frameworks, ISO standards, and FDA quality system regulations, with a focus on advancing safe and effective medical technologies.
Beyond her academic and professional roles, Afrah is actively engaged in the regulatory community. She serves as Project Manager for PDA’s Regulatory Affairs Interest Group, Student Chapter Lead for AGXPE New England, and a member of ISPE Boston, RAPS, and ASQ Medical Device Division. Through her leadership, conference presentations, and research initiatives, she is committed to driving innovation, regulatory clarity, and patient safety in emerging areas such as connected health, AI/ML, and combination products.
Thursday, October 9, 2025
11:15 AM - 11:30 AM EST