Torana Khubalkar
Quality, Regulatory and Clinical Leader | Passionate about Patient Safety & Driving Quality-Led Innovation in Healthcare
- Role
- Clinical Project Manager at Tulavi
- Location
- San Mateo, CA, US
- LinkedIn followers
- 500 followers
About Torana Khubalkar
My dedication to quality in medical devices is fueled by a potent combination of motivation, self-determination, and a relentless pursuit of excellence. This drive led me to not only earn a dental degree, but further my expertise with a Master\'s in Medical Technology Quality and a Regulatory Compliance certificate from St. Cloud State University. This unique blend of clinical understanding and quality mastery allows me to see the bigger picture when developing new products or refining existing ones.Throughout my career, I\'ve consistently proven my ability to build and lead cross-functional teams. My passion for innovation translates into highly effective initiatives that deliver exceptional results. From entrepreneurial ventures like Teeth Heal dental clinic to collaborations with digital therapeutic and pharmaceutical companies, I\'ve had the privilege of navigating diverse Quality Systems, each one enriching my understanding of the field.Key Achievements:Built complete Quality Management System for innovative medical device startup from ground upStreamlined supplier quality program resulting in 20% reduction in delaysReduced training time by 20% while improving compliance through innovative blended learningSuccessfully led FDA Pre-Submission strategy for breakthrough device classificationSpearheaded cross-functional quality initiatives across Clinical, R&D, and OperationsCurrently leading Quality Management at GraphWear Technologies, focusing on pre-market compliance and design controls for innovative medical devices. Previously strengthened post-market surveillance systems for De Novo-approved digital therapeutic at NightWare Inc.Expertise in:Design Controls & Risk Management (ISO 14971)Quality System Regulations (21 CFR 820)Clinical Investigation Compliance (21 CFR 812)Software Validation (IEC 62304)Audit Management & CAPA SystemsMy career is driven by the belief that robust quality systems are fundamental to bringing transformative medical technologies to market. I thrive on collaborating with diverse teams to solve complex challenges, whether it\'s optimizing design controls, strengthening supplier quality, or ensuring clinical investigation compliance.Seeking opportunities to leverage my blend of clinical knowledge, quality expertise, and leadership skills in organizations developing innovative medical technologies. Open to connecting with fellow quality professionals and medical device companies focused on advancing patient care through excellence in quality management.
Experience
Clinical Project Manager
Aug 2025 — Present
Education
VSPMs Dental College & Research Centre, Dighoh Hills, Hingna Road, Nagpur
Bachelor of Dental Surgery, Dentistry
2009 — 2013
St. Cloud State University
Master's degree , Medical Technology Quality
2020 — 2021
Skills
- Endodontics
- Cosmetic Dentistry
- Powerpoint
- Teeth Whitening
- Restorative Dentistry
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