Responsible for all the quality assurance activities, regulatory affairs, and Quality Management System in HeadSense Medical Ltd

Developed, implemented and maintained Document Control, Quality Control (Receiving Inspection, Non-conformances and MRB), Environmental Monitoring, Risk Management, CAPA, Supplier Quality Assurance, Return Material Authorization, Training, Internal Audits, Management Reviews, Continuous Improvement and Qualification TestingMaintained Quality Assurance on existing exo-skeletal product lines while providing developmental support, including verification and validation testing, on new implantable and exo-skeletal product linesProvided Quality Assurance support in submission for (class II) medical device to the FDA and EU Notify Bodies Responsibility for ISO certification (9001, 13485).PLCM – Product Life Cycle Management. Quality and regulatory aspects in development, production and service..Determine domestic and international labeling requirements for all products and target markets.Manage and/or support international regulatory activities, including Japan, EU, Australia, Canada and Mexico.Manage and/or support FDA submissions (510k) and Memorandum to File preparations

-Document Control-Quality Control (Receiving Inspection)-Non-conformance -Environmental Monitoring-Corrective and Preventive Actions-Supplier Quality Assurance-Return Material Authorization-Training-Internal Audits-Continuous Improvement-Calibrations