Luis Alberto Ramos Neira

· In-person and online assistance. · Travel medicine, on-demand consultations, and chronic disease monitoring. · First aid while traveling, medical assistance. · Freelance consulting on continuity of care, quality, and patient safety.

· Monitoring of due dates, reminders and escalations. · Implementation of CAPAs and subsequent efficacy tests (ECs). · Management and implementation of RCA. · Representing the CAPA system in internal and external audits. Successes · Successfully completed four audits with recertification in less than three weeks. · Led a crash plan that considerably reduced the CAPA backlog in twelve weeks. · Support in handling NCs and customer complaints. · Successful implementation of CAPA management meetings.

· Leading and improving the CAPA process, including software management. · Definition and support of the complaints process as well as process specifications. · Training of employees. · Coordination of CAPA circles and project planning based on CAPAs. Successes · Built and managed a global CAPA team with three employees. · Completion of MDR and IVDR audits and redesignations. · Redefinition of the CAPA process and training for the entire organization. · Reduce the CAPA backlog and improve accountability.

· Establishment of an ISO 13485:2016 and MDR compliant quality system for medical devices in the EMEA Region. · MDD-to-MDR transition and definition of efficient quality processes. · Training of employees on quality systems and processes. Successes · Led the project to develop a regional matrix QMS in sixteen countries. · Support for MDR transition for assigned product lines. · Coordination of GAP analyses at production sites to adapt to MDR requirements.

Double hatting position with the previous. · Global responsibility for medical processes. · KPIs and benchmarking. Stakeholders relations. · Internal standard medical practices harmonization. · Leading clinical governance: defining common KPIs, sharing experiences and continuous improvement. · Responsibility for patient safety: Analysis and management of corrective actions in the event of incidents. Successes · Contributing to the successful implementation of divestment projects.

· Development /promotion global clinical standards and processes. · Supporting quality compliance in respiratory centers and home care. · Conducting internal audits and participating in external certification audits. Successes · Development and implementation of a global business management system in eleven countries. · Leading teams to investigate and handle security incidents. · Introduction and monitoring of KPIs for quality improvement in local organizations.