Rafael A Pichardo

About Rafael A Pichardo

Achievements, by their very nature, boost a person’s self-confidence. The sensation of triumph is the one part of success that fuels a person’s drive to continue pursuing goals. Biomedical Engineer with a combined 10 years of experience in Manufacturing, Quality, R&D and academic/industry laboratories for the Life Sciences (biologics), Medical Devices (coating, AM/3DP, implants: metals/polymers, SaMD), and Therapeutics (enzymes, magnetic particles) industries.Former elite swimmer with an unbreakable and execution mindset.I am motivated by achievement and have a goal-oriented lifestyle with a deep commitment to success. I prefer unique, scalable, quality service, and business-to-business or practical solution-oriented concepts. A good fit for me is a company with a Collaborate Culture, where there is an inward focus with concern for integration. I thrive in Collaborate organizations that emphasize flexibility, discretion, and are made up of semi-autonomous teams. I value cohesion, a humane working environment, group commitment, and loyalty.I am a great strategic planner and decision maker, and I abide by results-based plans long into the future. I am driven, reliable, and hardworking, and an excellent problem solver and planner. I value agreements highly, and finances, schedules, and plans are respected and adhered to with only incremental adjustments as necessary. I am capable of wearing many hats, and I set high expectations for both myself and others, demanding measurable and consistent growth.I am direct and to the point as a business person. I am effective at delegating, and I empower and hold accountable capable partners and employees. I am a detail-oriented person and enjoy perfecting processes and working toward tangible results. I am conscientious and deliberate when making decisions, and my strengths include an eye for detail and accuracy, independence, dependability, persistence, follow-through, and organization.I am a good fit for a business where the sales are of a consultative, solution-based nature. I am able to build high trust and high credibility relationships with prospects. I am good at understanding the customer\'s business environment, critical business drivers, and high priority business initiatives and then crafting a solution to help the customer achieve their objectives. The consultative sale can be a complex, long-term process involving collaboration of both the buyer and the seller, and I am able to lay a solid foundation as an expert or consultant for future sales with the prospect.

Experience

1. Senior Consultant, Regulatory Operations, Cmc & Medical Device

   Cardinal Health

   May 2021 — Present

   Design, Development and Manufacturing. Global Medical Device Consulting. Global Regulatory Affairs, Global CMC, Digital Health, Digital Therapeutics (DTx).• Software Medical Devices (SaMD) strategist to include Technical File creation, design/development, validation/verification, product realization, and risk management per ISO 14971, and training. Projects include decommissioning due to conflict between marketing/labeling of UK medical device and medicine regulations; transition of product from Class 1 to Class 2A per MDR in Belgium; and vendor/classification changes in Australia/New Zealand • Incorporate eCTD revisions for small molecule, for variation of container closure system for markets in Taiwan, Korea, Finland, Spain, Estonia, Bulgaria, Morocco, and Austria• Assessed regulatory requirements for US approval and marketing of a European device under EPA/FDA regulation for either animal or human intended use, as well as state registration constraints of time and cost• Developed and trained 30+ GCMC Scientists on Medical Device ISO 14971 Risk Management: four-part, 1-hour sessions to share knowledge, experience, and good practice of approaching and applying the standard with real-life examples such as tools, templates, checklists, FMEA, evaluation, and review

Education

• University of Florida

  Master of Science - MS, Biomedical/Medical Engineering

• University of Florida

  Bachelor of Science - BS, Biological/Biosystems Engineering