Mohit Saini Email & Phone Number

● Spearheaded regulatory submissions, including 510(k), PMA, and IDE, ensuring 100% compliance with FDA guidelines. ● Ledpost-market surveillance by preparing and submitting MedWatch Form 3500A reports, adhering to FDA 21 CFR Part 803. ● Enhanced team performance by implementing Lean Six Sigma tools, reducing reporting timelines by 40%. ● ManagedCAPAinvestigations to address adverse events, ensuring alignment with ISO 14971 and FDA requirements.

Gurugram, Haryana, India

● Prepared comprehensive Technical Files to secure CE Marking under MDD 93/42/EEC. ● Ensured end-to-end compliance with ISO 13485 and 14971 for risk management in medical device manufacturing. ● Reduced regulatory approval timelines by 20% through process optimization and close collaboration with notified bodies. ● Managed regulatory communication for De Novo submissions, ensuring documentation accuracy.

Gurugram, Haryana, India

Managed a team of 8 people, supervising warehouse inventory, storage, and distribution of medicationsto ensure timely availability and adherence to quality standards.Monitored stock levels and optimized inventory turnover, achieving 85% accuracy in stock forecasting.Reduced excess inventory costs by 15%, ensuring seamless medication supply chain operations.

Bhiwani, Haryana, India

● Supported clients in compliance with medical device approvals, including Technical File preparation for CE Marking. ● Conducted gap analysis for ISO 13485 and FDA submissions, ensuring readiness for audits. ● Prepared risk management documents compliant with ISO 14971 to streamline CAPA and adverse event processes. ● Developed regulatory roadmaps for 510(k) and De Novo submissions, ensuring efficient pathways to approval.

Bhiwani, Haryana, India

Managed drug inventory levels, ensuring sufficient medications and supplies to meet patient needsthrough effective ordering and replenishment.Monitored inventory by analyzing usage data and forecasting future needs, maintaining optimal stocklevels at all times.Verified deliveries against purchase orders, resolving discrepancies to ensure accurate and timely supply management.Ensured compliance with storage regulations by monitoring expiration dates, discarding expired ordamaged drugs, and maintaining accurate inventory records.Collaborated with healthcare providers and communicated with suppliers to facilitate timely ordering and delivery, supporting quality patient care