Dr. Vidhi Patel

I am a Master’s student in Regulatory Affairs at Northeastern University with a PharmD background and a strong focus on medical device regulation and safety. My academic training has given me hands-on exposure to FDA and global regulatory frameworks, including device classification, risk management, design controls, and post-market surveillance. Through applied coursework and projects, I have worked on medical device risk assessments, hazard analysis, human factors engineering, usability considerations, and post-market monitoring strategies. I have experience evaluating potential failure modes, developing risk mitigation approaches, and aligning device safety controls with regulatory expectations to support safe and effective product use. I bring strong technical writing, literature review, and cross-functional collaboration skills, along with a detail-oriented and patient-centered approach. I am actively seeking Co-Op opportunities in medical device regulatory affairs where I can contribute to regulatory submissions, risk management activities, and compliance efforts while continuing to grow within the medical device industry.