Alan Marcovecchio

Co-founder & VP Clinical, Regulatory & Quality @Atacor Medical, Inc

San Clemente, CA, US
EMAILS
a•••@atacor.com
MOBILE NUMBERS
+19•••••••76

Signup · Get unlimited contacts

WORK HISTORY

Dec 2014 — Present

Co-founder & VP Clinical, Regulatory & Quality @Atacor Medical, Inc

View department →

EDUCATION

1997 — 1999

University of Minnesota

MS, Electrical Engineering

1992 — 1996

Case Western Reserve University

BS, Electrical Engineering

SKILLS

CardiologyRegulatory AffairsFda Advisory PanelGmpValidationIso 13485Regulatory SubmissionsGlpS-IcdU.s. Food and Drug Administration (Fda)IsoFdaIcdQuality AssurancePmaR&DClinical DevelopmentDefibrillatorsQuality SystemV&VCorrective and Preventive Action (Capa)DefibrillatorDesign DossierCe MarkingResearch and Development (R&D)Clinical TrialsDesign of ExperimentsMedical DevicesClinical ResearchCapaDesign ControlPacemakersBiomedical EngineeringIde

ABOUT ALAN MARCOVECCHIO

25+ years of experience in the medical device industry, with core competencies in Clinical Studies, Quality Management Systems and Regulatory Affairs.Clinical Studies experience includes design, approval and execution of human clinical trials, ranging from early feasibility to pivotal trials for regulatory approvals and post-approval studies. Regulatory Affairs experience includes 510(k) submissions, original PMA submissions, FDA Advisory Panel Meetings and CE Marking for Medical Devices.Additional experience includes ISO 13485 & 21 CFR 820 Quality Systems, technical support of implanted devices in a hospital/clinic setting, animal studies, cadaver studies and algorithm design for implantable pacemakers/defibrillators.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.