Vidushi Dhakad

I am a Quality & Regulatory professional with a Master’s in Regulatory Affairs from Northeastern University and a Bachelor of Pharmacy from the University of Mumbai. My experience spans Design Quality Assurance, Regulatory Consulting, and Quality Systems across medical devices and pharmaceuticals. At Boston Scientific, I supported both sustaining engineering and new product development, applying IEC 60601, ISO 14971, and IEC 62304 standards to ensure compliance. I developed design verification templates, authored technical reports, maintained risk management files, and contributed to software FMEAs and usability studies. Earlier, as a Regulatory Affairs Consultant, I crafted strategies for Class II devices, navigated FDA pathways, and performed risk-benefit assessments. I am passionate about advancing safe, compliant, and patient-centric medical technologies, and I bring skills in quality engineering, risk management, regulatory documentation, and product lifecycle support. With strong cross-functional collaboration and problem-solving abilities, I thrive in dynamic environments where quality, safety, and innovation intersect. 📌 Specialties: ISO 13485 | ISO 14971 | IEC 60601 | IEC 62304 | IEC 62366 | FDA 21 CFR 820 | Design Controls | Risk Management | FMEAs | Regulatory Strategy | Technical Documentation