Vaibhav Vaidya
Helping MedTech & IVD Companies Navigate EU MDR, PMCF, CER & CDSCO | Toxicology (PDE/OEL), Clinical Trials & Materiovigilance | Business Lead @ Bioexcel
- Role
- Business Development Lead at Bioexcel
- Location
- Nagpur, IN
- LinkedIn followers
- 500 followers
About Vaibhav Vaidya
At Bioexcel, I partner with innovators in In Vitro Diagnostics and Medical Devices to help them navigate complex clinical and regulatory landscapes. From performance evaluations to post-market clinical follow-up (PMCF), I bring a strategic lens to clinical operations—ensuring your studies don’t just meet compliance, but drive momentum. • Deep understanding of EU MDR and IVD Regulation (IVDR) clinical requirements • Expertise in aligning clinical data strategies with regulatory timelines • Strong network and collaborative approach to reduce trial delays and bottlenecks • Support across CRO selection, vendor coordination, and clinical program design • QA/RA leaders managing EU submissions and CE Marking readiness • R&D teams needing evidence plans for novel diagnostics or device claims • Clinical Operations heads looking for faster trial execution and smoother audits • Founders and strategy teams scaling from prototype to global launch 🤝.
Experience
Business Development Lead
Aug 2023 — Present · Nagpur, IN
Education
Saraswati Vidyalaya
Secondary School Certificate
Dr. Ambedkar College, Nagpur
High School Diploma
2014 — 2016
Savitribai Phule Pune University (SPPU)
Master of Arts - MA
2020 — 2022
Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)
Bachelor of Science - BS
2016 — 2019
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