I am a postgraduate (M.Pharma), having 10 years of experience in quality assurance and regulatory affairs field of Pharma and Medical Devices. Currently I am working as a quality and Regulatory Affairs Officer in a MNC ?Key skills: Quality Documentation, SOP writing, Validation documentation, Computer System validation. CTD dossiers, eCTD dossier, DMF writing (in Pharma). Preparation of regulatory submissions of medical devices, Maintain compliance of company with ISO 13485 and 93/42/EEC and 21 CFR 820 regulations and guidelines.