Rahul Priyadarshi is the Director of Chitransh Groups Pvt. Ltd. and a highly experienced Quality Assurance and Regulatory Affairs professional with more than 21 years of experience in the medical device industry. He has extensive hands-on expertise in managing quality systems, regulatory compliance, and global approval processes for a wide range of medical devices.

Professional Experience

Over the course of his career, he has held senior leadership roles as Manager – QA & Regulatory Affairs in reputed medical device manufacturing organizations. His professional journey reflects extensive hands-on experience in managing quality systems, regulatory compliance, and supporting medical device manufacturers in achieving national and international regulatory approvals.

Regulatory & Technical Expertise

Rahul Priyadarshi has deep expertise in the implementation and maintenance of ISO 9001 and ISO 13485 Quality Management Systems, Indian Medical Device Rules (MDR) 2017, and European regulatory requirements including CE compliance under EU directives. His core competencies include Technical File preparation and review, Risk Management, Clinical Evaluation, Post-Market Surveillance, and Essential Safety Requirements documentation.

Audits & Compliance Management

He has successfully led internal and external audits, including Notified Body audits, managed regulatory submissions for Indian and international markets, and overseen validation of processes, equipment, clean rooms, and sterilization systems. His experience also includes vigilance reporting, recall management, CAPA implementation, deviation handling, supplier qualification, and pre-dispatch inspections.

Leadership Approach

Under his leadership, Chitransh Groups Pvt. Ltd. focuses on delivering practical, compliant, and cost-effective regulatory solutions tailored to client needs. His approach combines strong regulatory knowledge with real-world manufacturing experience, enabling clients to achieve approvals efficiently while maintaining long-term compliance and product quality.

Education & Certifications

Rahul Priyadarshi holds a Bachelor’s degree in Chemistry and an MBA in Operations. He also holds professional certifications including ISO 13485 Internal Auditor, Risk Management (ISO 14971) awareness, and specialized training in microbiology and bacterial endotoxin testing.

Through Chitransh Groups Pvt. Ltd., he continues to support medical device manufacturers ranging from startups to established organizations in strengthening quality systems, meeting regulatory expectations, and expanding into national and global markets with confidence.