Senior level management with extensive experience in the medical device industry. Authoring SOPS, implementing, executing and maintaining a compliant QMS in accordance with applicable regulatory standards. Lead auditee for regulatory inspections and audits (i.e. EN/ISO 13485, 21 CFR 820, CMDR). Global RA procedures for medical device registration requirements. Knowledge of 510(k) and NB Technical File submissions for CE Mark. Clinical and laboratory back ground in blood banking / transfusion medicine / immunohematology