Clinical Affairs expert in building and implementing Clinical & Regulatory Strategy for Medical Devices and Drugs. Experienced in EU MDR Transition & CDSCO IMDR - 2017 registration and renewal of medical device falling under EU MDR class I, Class III & CDSCO Class-A,B,C,D classification.Setting up ISO processes and taking the product to CE and USFDA (21 CFR Part 820, 510k) registration process.Has experience of handling Global Clinical Operations with different product categories such as Ophthalmic, Orthopedics, Dermatology, Urology etc. Hands on experience in ISO 14155 (Clinical Investigation) and other device specific performance standards to develop and deploy different processes.Experienced in analysis and remediation of documents such as Risk Management File, Clinical Evaluation Report, GSPR, labels, IFU, SOP etc. Planning, Designing and Managing complete Outsourcing of Clinical Studies (Global & Domestic)Extensive experience in Clinical Trials, Bioequivalence studies, PK-PD studies and Multi-center patient based clinical end-point studies for various dosage form (Oral Solids/Topical/Injectables) for various regulatory agencies. Has ground level working experience of Clinical Trial Management, Project Management, Evaluation and selection of CRO's/Clinical Sites, Clinical Monitoring, Risk based monitoring, study start up activity, Budget and financial activity etc.Has extensive knowledge and experience in Audits, process improvements (CAPA) and Project ManagementProject Management: Project Estimation, Resource Planning, Monitoring the project schedule and Review of offshore team deliverable. International team Coordination (Europe, India and USA). Offshore team training and development.Areas expertise in:➡️ Clinical Trial Management (Medical Device & Drugs) ➡️ Site handling and monitoring➡️ IMDR -2017: Indian Medical Device Regulation (Outstanding)➡️ EU MDR: MDR 2017/745 (Intermediate)