Divya Jyothi Gajavalli

At Spectra Medical Devices, my internship revolved around ensuring rigorous compliance with FDA regulations, particularly in 510(k) submissions and audit support. Our team's collaborative efforts were instrumental in upholding product safety and efficacy, a testament to our shared commitment to patient care and sector advancement. Currently, as a Regulatory Affairs student at Northeastern University, I am honing my expertise in medical devices, a field where my practical experience in CE marking, ISO 13485, and regulatory submissions directly informs my academic pursuits. My goal is to bridge theoretical knowledge and industry practice, fostering innovation while maintaining the highest regulatory standards.