Gautam Singh Rathore's Biography

Gautam Singh Rathore, Assistant Manager, QVC Certifications Pvt. Ltd, India

A results-driven Regulatory Specialist with extensive experience in Medical Devices, Pharmaceuticals, Nutraceuticals, and Food Industries, specializing in Quality Management Systems, Risk Control, Clinical Evaluation, and Regulatory Harmonization in alignment with WHO Global Atlas standards. A graduate in Biotechnology (B.Sc. Hons.) from Amity University, Noida, with a proven track record in implementing and enhancing regulatory frameworks. Currently serving as Assistant Manager - Regulatory Affairs at QVC Certifications Pvt. Ltd., managing EU MDR and IVDR compliance, CDSCO audits, technical documentation reviews, and training programs. Previously held the position of General Manager & Operations Head at Venkatramna Industries, leading ISO 9001:2015 implementation and pharmaceutical manufacturing operations, with additional expertise in ISO 13485 and ISO 22000 compliance. Founder of SCIENCE ARENA, a blog on healthcare and science innovations, and creator of a blog dedicated to Medical Device & IVD Regulatory topics. Published research on antimicrobial peptides in the International Journal of Pharmaceutical Sciences Review & Research and contributed to significant projects, including FDA health data collection and the development of antimicrobial nano-silver paints.A results-driven Regulatory Specialist with extensive experience in Medical Devices, Pharmaceuticals, Nutraceuticals, and Food Industries, specializing in Quality Management Systems, Risk Control, Clinical Evaluation, and Regulatory Harmonization in alignment with WHO Global Atlas standards. A graduate in Biotechnology (B.Sc. Hons.) from Amity University, Noida, with a proven track record in implementing and enhancing regulatory frameworks. Currently serving as Assistant Manager - Regulatory Affairs at QVC Certifications Pvt. Ltd., managing EU MDR and IVDR compliance, CDSCO audits, technical documentation reviews, and training programs. Previously held the position of General Manager & Operations Head at Venkatramna Industries, leading ISO 9001:2015 implementation and pharmaceutical manufacturing operations, with additional expertise in ISO 13485 and ISO 22000 compliance. Founder of SCIENCE ARENA, a blog on healthcare and science innovations, and creator of a blog dedicated to Medical Device & IVD Regulatory topics. Published research on antimicrobial peptides in the International Journal of Pharmaceutical Sciences Review & Research and contributed to significant projects, including FDA health data collection and the development of antimicrobial nano-silver paints.

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