Tapan N

Greater Boston Area United States

Graduate Student at Northeastern University,Regulatory Affairs in Drugs & Medical Devices, Seeking for Full-time positio

Medical / Health Care / Pharmaceuticals

More than two years of working experience in Regulatory Affairs for drugs and medical devices. Experienced in documentation, assistance in troubleshooting market complaints and audits for various markets ( US, Canada, EU, Brazil, etc.) for both drugs and medical devices, and compilation of technical dossier (for devices) or drug master file (DMF). Skills: Regulatory submissions and documentation, QMS, cGMP and CMC compliance, change controls and quality management systems, new product development, clinical research, IND, NDA, ANDA, IDE, 510(k), PMA, IVD, MDD (Medical device Directives), CAPs (conformity assessment procedures), BLA, EU filing, other international filing and registrations,...