Raymond Hernandez

· Strategically manage and execute safety and performance activities for pre- and post-market medical devices, ensuring patient safety throughout the product lifecycle.

· Evaluate device performance, escalate safety signals, and provide evidence-based medical safety input to internal and external stakeholders.

· Collaborate with cross-functional teams (Pre/Post Market Quality, Clinical, Regulatory, Failure Analysis Lab, and Post-Market Surveillance, Reliability) to ensure compliance with regulatory and quality system standards.

· Assess and escalate safety issues, including changes in severity/frequency of known events or newly identified risks, for investigation and resolution.

· Risk document management and collaboration (pFMEAs, uFMEAs, dFMEAs, PHAs, Hazard and Harms.)

● Project Manager for post-market surveillance remediation, overseeing non-compliant events and clinical remediation processes.

● Led the Field Corrective Action (FCA) Team, coordinating training and action plans for product safety issues.

● Spearheaded the implementation of EU MDR guidelines, ensuring compliance through targeted training and timely execution.

● Provided subject matter expertise in post-market surveillance, regulatory reporting, and medical writing for adverse events, trending/signaling, and clinical studies.

● Supported FDA, BSI, and MDSAP audits, ensuring adherence to all regulatory requirements.

Interim MDR/Vigilance Manager (1 year position): October 2020-2021

· Oversaw day-to-day operations, including WIP, remediation, FCA, and onboarding of contractors and full-time staff.

Senior MDR/Vigilance Supervisor June 2017 – June 2018

● Oversaw day-to-day operations, including WIP, remediation, FCA, and onboarding of contractors and full-time staff, and Remediation lead

· Provided implant, technical, and clinical support for bradycardia, tachycardia, and CRT product lines throughout the territories hospitals, clinics, and doctors office.

· Delivered education, and in-service training to physicians and healthcare professionals.

· Collaborated on clinical research studies, supporting principal investigators and ensuring product safety and risk management.

Clinical Patient Support/Sales Support

● Delivered clinical training and support for physicians, staff, and patients nationwide. (National PSR staff/physician Trainer)

● Led CRM training and education for EP/Cath Lab/OR staff and device teams.

● Partnered with medical directors to standardize therapeutic and diagnostic care policies for MRI-compatible CRM devices.

● Clinical study research: Coordinated cardiac device implants and research clinical trials in collaboration with principal investigators, clinical staff, and provide product surveillance for safety and risk management.

· Managed clinical trials for cardiovascular devices and medical therapies, collaborating with principal investigators.

· Developed hospital-wide data reporting systems and maintained accreditations for multiple cardiovascular service lines. (Chest Pain Center, Cath Lab, and EP Lab, Vascular Lab, Coumadin Clinic, Heart Failure Clinic)

· Organized community cardiovascular health events, symposiums, and physician education programs.

Cardiac Rehab Charge Nurse /Clinical Nurse 3/Cardiac Step-Down Unit

· Provided critical care and rehabilitation support to cardiac patients during inpatient and outpatient recovery.