 A result oriented professional with 25 years of rich experience in Quality Assurance & Regulatory Affairs functions of Medical Device (Condoms,Medical Gloves,Urology Catheter,Surgical Blades,Scalpels,Patient Monitoring System,Cardiac Stents and Blood Cell Separator-Class III) and OTC drugs (Dr.Scholls Foot care Cream & Durex Play Vaginal Lubricants)manufacturing organisations. Proficient in spearheading the implementation and maintenance of Quality Management System as Management Representative. Well conversant in planning & scheduling effective maintenance schedule for enhancing quality and regulatory systems Deftness in devising, implementing, monitoring, reviewing and revising Total Documentation System (QMS) as per required Countries Regulation, cGMP,21 CFR 820, ISO 9001:2000, ISO 13485:2003, MDD/93/42/EEC. Proficient in design & development of new systems, improving the existing Systems & Products by continuous monitoring, analysis for continual improvement.  Qualified Lead Auditor for ISO 900I:2000. Qualified Six Sigma- Green Belt. Demonstrated analytical, problem solving and organisational ability coupled with strong communication and relationship management.Specialties: Management Representative for ISO 9001:2000,ISO 13485:2003,MDD/93/42/EEC,21 CFR 820.