A meticulous and performance-driven Quality Compliance & Regulatory Affairs expert with a strong diverse experience in handling end-to-end implementation of quality management System (ISO 13485:2016/ 21 CFR 820), risk management (ISO 14971:2007 and EN ISO 14971:2012), clinical trial research & documentation, regulatory submissions in Medical Device industry and medical writing like SOPs, quality plans, quality manual, quality policies, work instructions, SaMD documentation and HIPAA policies. Mentor, guide, and train team members on ISO and regulatory requirements like 14971, 62366, 14155, 13485, IEC 62304, 21CFR Part 820, 21CFR Part 803, MEDDEV Guidelines, SaMD and MDR 2017/745.