Arunkumar Gujja

Background

About Arunkumar Gujja

A competent and consummate professional writer with demonstrated potential of 8.5 years in the Medical device domain—Medical writing, Safety narrative, MedDRA coding, Case processing with Team management, streamlining quality operations, controlling, and coordinating in the product improvement activities, while always propelling the team, personnel to achieve service excellence along with organizational objectives and well trained in handling the gamut of functions related to Medical Device Directives (MEDDEV guidelines and MDR regulations); Clinical trial process/Research; Ethics & Good Clinical Practice and ICH-GCP Guidelines. • Having 6+ years of experience in writing/reviewing of “Clinical Evaluation Plans (CEP), Clinical Evaluation reports (CER), Post market Surveillance documents (PMSP and PMSR), Post-Market Clinical Follow-up (PMCFP and PMCFER), Summary of Safety and Clinical Performance (SSCP) Patient & HCP versions, State of the Art (SOTA), Key Safety & Performance parameters, Risk Benefit analysis for medical devices (Class I, Class IIa, Class IIb & Class according to MEDDEDV 2.7/1 Rev. 4 and EU MDR 2017/745". • Capable of working remotely with multidisciplinary teams to produce high-quality content to exceed clients' expectations. Deadline-driven and motivated self-starter.