Vipul Rathore

Vipul Rathore, Ph.D., has extensive work experience in various scientific and quality management roles. Vipul is currently the Lead Auditor and Technical Document Assessor for TÜV Rheinland Group, where they audit the quality management systems of non-active medical device and IVD device manufacturers. Vipul is also an IVDR expert and technical documentation assessor for IVD products that impact patient, user, and consumer health and safety.

Prior to their current role, Dr. Rathore worked at TÜV Süd as a Lead Auditor, Technology Assessor, and in vitro Diagnostics specialist from 2017 to 2021. In this position, they were responsible for auditing quality management systems, serving as a point of contact for clients, and managing QMS certifications and change management requirements.

Before that, Dr. Rathore served as a Senior Research Scientist at Exact Sciences from 2014 to 2017. In this role, they led research on protein biomarkers for cancers, conducted feasibility testing for molecular markers, and optimized assays to increase sensitivity of marker detection.

From 2007 to 2013, Dr. Rathore worked at Immucor, Inc. as a Scientist II, overseeing the commercialization of an anti-platelet antibody assay. Vipul also contributed to patent searches, supported regulatory submissions, and improved operations through SOP and QAP modifications.

Dr. Rathore has also held positions at Geneva Laboratories, Inc., Hologic Gen-Probe, Waukesha, GTI Diagnostics, BloodCenter of Wisconsin, Medical College of Wisconsin, and the Cancer Research Institute in Mumbai, India. Their roles in these organizations involved directing laboratory operations, leading research projects, developing assays, and conducting grant writing.

Overall, Dr. Vipul Rathore's work experience spans various scientific and quality management roles in the medical device, diagnostics, and research fields.

Vipul Rathore, Ph.D., received their Bachelor of Science (BSc) in Biochemistry, Microbiology, and Chemistry from Nagpur University, Sindhu Mahavidyalaya, Panchpaoli in 1990. Vipul continued their education at Nagpur University, completing their Master of Science (MSc) in Biochemistry in 1992. Vipul then pursued their doctoral studies at the University of Mumbai, earning their PhD in Applied Biology in 1997. In 2017, they obtained a Regulatory Affairs Certificate in Medical Devices from RAPS Online University.