Clinical Affairs And Regulatory Affairs Managerin
CurrentClinical Affairs, Regulatory Affairs, Medical Writer, Clinical Studies (ICH E6, GCP, EU VO 536/2014), Monitoring and reporting in multi national trials, Clinical Study Reports, Project Management, AE/SAE monitoring and reporting, QMS (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MEDDEV 2.7/1 rev 4), Clinical Investigation (ISO 14155)