Vrusti Patel

Background

About Vrusti Patel

Passionate about bridging the gap between groundbreaking research and regulatory compliance, I am currently pursuing a master’s degree in Regulatory Affairs at Northeastern University, where my coursework covers drugs, biologics, and medical devices, with a focus on regulatory submissions, clinical trial design, and global compliance standards. My background includes a bachelor’s in pharmacy and hands-on experience as a Clinical Research Coordinator at Oncowin Cancer Centre, where I supported Phase oncology trials. I ensured compliance with GCP and ICH E6(R2) guidelines, managed the Trial Master File, and coordinated daily trial operations. This experience strengthened my understanding of clinical documentation, regulatory expectations, and site-level challenges, skills that translate well to clinical, regulatory, and quality roles in the medical device industry. I am currently interning at Exelint International, a medical device company, as a Regulatory Affairs and Quality Assurance Intern. I contribute to the EU MDR transition, supported FDA 510(k) and EU documentation, helped with DHF remediation and CAPA, prepared PSURs, performed labeling updates, and conducted incoming inspections using Qualio (eQMS). This experience gave me valuable insight into the regulatory and quality systems specific to medical devices. I’m looking for an opportunity to apply my skills and knowledge while continuing to learn and grow in the regulated industry.