IVD Medical Devices | R&D, QA/RA, Manufacturing
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Mukul | IVD Medical Device Expert | R&D, Regulatory Affairs, Manufacturing & Quality Leadership
I’m a healthcare innovation leader with 17+ years of experience in the IVD medical device industry, specializing in R&D, Regulatory Affairs, Quality Assurance, and Manufacturing Operations. I have successfully led the development, validation, and regulatory approval of over 20 diagnostic products, including HIV, Hepatitis, Syphilis, Dengue, Malaria, COVID-19, Sickle Cell Anemia, and Ferritin, across ELISA, Lateral Flow, and CLIA platforms.
I’ve held leadership roles with Voxtur Bio, Transasia (Erba), Avantor, Span Diagnostics (Arkray), Bhat Biotech, J Mitra, and NBRI-CSIR, where I’ve built high-performing teams, improved manufacturing efficiency, and ensured global compliance (ISO 13485, EU-IVDR, CDSCO, CE, WHO).
Certified in Six Sigma (Green Belt) and ISO 13485 Internal Auditing, I bring a unique combination of scientific insight and operational excellence. My mission is to deliver innovative, scalable, and regulatory-compliant diagnostic solutions that improve lives.
Let’s connect if you’re looking for leadership in IVD product innovation, global compliance, or plant operations.
Mukul | IVD Medical Device Expert | R&D, Regulatory Affairs, Manufacturing & Quality Leadership
I’m a healthcare innovation leader with 17+ years of experience in the IVD medical device industry, specializing in R&D, Regulatory Affairs, Quality Assurance, and Manufacturing Operations. I have successfully led the development, validation, and regulatory approval of over 20 diagnostic products, including HIV, Hepatitis, Syphilis, Dengue, Malaria, COVID-19, Sickle Cell Anemia, and Ferritin, across ELISA, Lateral Flow, and CLIA platforms.
I’ve held leadership roles with Voxtur Bio, Transasia (Erba), Avantor, Span Diagnostics (Arkray), Bhat Biotech, J Mitra, and NBRI-CSIR, where I’ve built high-performing teams, improved manufacturing efficiency, and ensured global compliance (ISO 13485, EU-IVDR, CDSCO, CE, WHO).
Certified in Six Sigma (Green Belt) and ISO 13485 Internal Auditing, I bring a unique combination of scientific insight and operational excellence. My mission is to deliver innovative, scalable, and regulatory-compliant diagnostic solutions that improve lives.
Let’s connect if you’re looking for leadership in IVD product innovation, global compliance, or plant operations.
Master In Biotechnology from Jiwaji University, Gwalior and MBA in project Management
