ALINA ALLAWALA

Regulatory Affairs Specialist with proven experience supporting global regulatory strategy and market access for in vitro diagnostic (IVD) medical devices across U.S. and international markets. Expertise in regulatory impact assessments, product lifecycle management, international registrations, technical documentation, labeling compliance, and change control within complex regulatory environments. Adept at evaluating global regulatory requirements, mitigating regulatory risk, and collaborating with cross-functional teams to accelerate product commercialization while maintaining compliance with FDA and international regulations. Recognized for strong analytical thinking, attention to detail, and the ability to manage multiple priorities in fast-paced, global organizations. Holds a Master of Science in Medical Device Innovation with concentrations in Regulatory Affairs, Quality Systems, and Operations Management.