Luis Leyva
Sr Field Assurance Specialist at Endologix Llc
Based in Orange County, United States
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Seniority
Staff
Department
Finance & Accounting
Location
Orange County
Industry
Medical Device
Company size
466
Contact information
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l•••••••@endologix.com
Phone
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Background
About Luis Leyva
I’m a Regulatory Affairs and Post-Market Surveillance professional with 13+ years of experience in the medical device industry. My expertise includes medical device complaint reporting (Class II & global vigilance submissions (FDA, EU-MDR, MDV, ROW), and CAPA investigations. I’ve led full-cycle complaint investigations, conducted clean-room evaluations, and authored 200+ adverse event reports across multiple product lines. I’m passionate about patient safety, quality systems, and regulatory compliance. Skilled in tools like Salesforce, TrackWise, and CATSWeb, I’ve consistently delivered 100% on-time reporting while improving product feedback loops and reducing repeat incidents. I’m currently open to new opportunities in Orange County or remote roles in: • Medical Device Complaint Reporting • Post-Market Surveillance • Regulatory Affairs & Compliance Bilingual in English and Spanish | Certified in OSHA Bloodborne Pathogens | Hepatitis B & COVID Vaccinated
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