Raymond Kelly
Chief Regulatory Officer @Arazy Group Consultants Inc
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WORK HISTORY
Chief Regulatory Officer @Arazy Group Consultants Inc
Vancouver, BC, CA
Submit and receive FDA clearance on approximately forty 510(k) applications annually. Have submitted hundreds of 513g, presubmission, SIR, EUA, pEUA, SBD, MDL, GUDID submissions. Developed successful regulatory strategies, submitted, and received approvals for 510(k), CBER 510(k), MAF, HUD, Q-submission, and Annual Reports (IDE/PMA). Assisted clients with Covid-19 emergency use authorizations including EUA and pEUA applications with FDA. Have arranged and attended many meetings or teleconference calls with FDA and average 16 annually. Assisted with development of the Licensale platform which manages simultaneous global regulatory applications. Successfully manage client product testing programs using partner labs including human factor/usability studies, biocompatibility studies, sterilization validations, distribution and packaging validations, microbial ingress, particulates, shelf life and end of life testing, electrical and EMC safety testing, software and cybersecurity validations, animal and bench performance testing, risk assessments, flammability, filtration, preconditioning-cleaning-disinfection validations for reprocessed equipment, and radiation safety reporting as part of client applications or AI responses. Established substantial equivalence discussions to predicate devices to support 510(k) applications, and 515i reclassifications. Performed regulatory strategy surveys, recalls and PMS, and other RA support functions. Redact documents and request documents via FOIA. Provide reports when needed on regulatory and/or quality topics for medical devices and combination products for US.
EDUCATION
Werner-Siemens Fachhochschule
Dipl.-Ing. (FH), Electrical, Electronics and Communications Engineering
Defense Mapping Agency, Defense Mapping School Fort Belvoir
Technical Drafting Specialist
SKILLS
ABOUT RAYMOND KELLY
I am a regulatory affairs strategist with 20+ years in global MedTech submissions. 140+ FDA approvals (510(k), de novo, AI/ML devices, IVD, implants). Creative thinker. Compliance innovator. Technology adopter. Human-centered approach to regulatory excellence.Global RA Strategist with 140+ Approvals | Expert in FDA, HC, AI & Complex SubmissionsI am a Regulatory Affairs leader with over two decades of experience bringing advanced medical devices to global markets. I am known for delivering innovative, strategic solutions, not just working hard, but working effectively. I combine regulatory intelligence, cross-disciplinary collaboration, and emerging technologies to help innovators confidently meet global compliance standards.Core Expertise• U.S. FDA & Health Canada submissions (510(k), de novo, IND, IDE, HUD, HDE)• Regulatory testing strategy, lab coordination, and validation• Recall handling, agency response, and labeling• SaMD, AI/ML, implants, IVD, catheters, biomaterials• Licensale®, Regislate™, Arazy AI™ platform user & testerI look beyond checklists. I question assumptions, identify hidden pathways, and collaborate openly. I bring creativity and critical thinking into a space often perceived as rigid. That means faster approvals, stronger submissions, and less burnout for teams.Selected Achievements• Over 120 successful 510(k) clearances• Dozens of complex de novo and global filings• Contributor and early adopter of AI-based RA platformsI am Florida-based. I am passionate about gardening, problem solving, and learning languages (German, Spanish, Italian). I aim to bring the same care and curiosity to both my personal and professional life.Let’s Connect: I\'m here if you need insight, collaboration, or support navigating complex regulatory landscapes.
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