Lina M Alzate

Los Angeles, CA

Medical Devices

Johnson & Johnson
Senior Safety Officer
Clinical Safety Risk Management
Consultant
Heartware Inc Jun 2013 - Dec 2014
Senior Director Clinical Safety
Biosense Webster Dec 2012 - Jun 2013
Medical Safety Officer
Cordis Jun 2010 - Jun 2013
Medical Director Complaint Handling, Risk Management and Product Safety

University of Minnesota 2001 - 2003
Master of Science, Masters, Biomedical Engineering Universidad Pontificia Bolivariana 1989 - 1996
Doctor of Medicine, Doctorates

Medical Devices
Fda
Iso 13485
Cross Functional Team Leadership
Quality System
Capa
Design Control
Cardiology
Iso 14971
Clinical Trials
Biomedical Engineering
Clinical Research
Validation
Product Safety
Regulatory Affairs
U.s. Food and Drug Administration
Gcp
Process Improvement
Fmea
21 Cfr Part 11
Complaint Management
Failure Mode and Effects Analysis
Corrective and Preventive Action
Interventional Cardiology
Presentation Skills
Business Process Improvement
Risk Management
Post Market Surveillance
Adverse Event Reporting
Clinical Evaluation Report
Health Hazard Evaluation
Procedure Development
Adult Education
Curriculum Design
Field Training
Technical Training
Regulatory Reporting
Annual Reports
Risk Assessment
Recalls
Sop Development
People Management
Team Development
Management Review
Performance Metrics

English
Spanish

Certified Technical Trainer (Ctt+)
Ibhre (International Board of Heart Rhythm Examiners)