Rafael Pozos

About Rafael Pozos

I am a results driven Problem Solver, Senior Risk Management Practitioner and Quality Engineer and Regulatory Affairs professional specializing in Risk Management, Process Improvement, Regulatory Deficiency Remediation, Medical Device Cybersecurity, and new product development. I am known for my tenacity, practicality, consistency, unwavering commitment to quality and continuous improvement. I take the situation presented to me, define and implement critical systems and procedures, updating where already present to help correct the deficiency identified and others that may have been hidden with absolute candor through the entire process. I have used my understanding of engineering, quality, regulatory, and my desire to learn and grow in those areas ensure the success of two 510(k) submissions and other regulatory filings. I further used this to establish and optimize risk management systems compliant with ISO 14971 within a 21 CFR 820 compliant quality system. With input from engineers and other stakeholders, I simplified said systems while maintaining the same level of rigor, leading to significant cost savings. What differentiates me from others? I move between and can interpret the worlds of Software development, Regulatory Affairs, Quality Assurance, and Risk Management with ease. With a unique ability to learn complex subjects quickly and at a high level of proficiency, I look flexibly for a high quality result that goes beyond the intent of any relevant regulation or standard. Quality and Regulatory are there to help the business grow by ensuring it stays within the relevant regulations. I am here to help you innovate within the regulations to help your business grow and thrive and produce a high quality product that is safe, reliable, and makes a positive impact for your patients and business.

Experience

1. Samd Scheme Manager & Clinical Evaluation Specialist

   BSI

   Jan 2025 — Present

   Responsibilities• Maintinence of MDR, UKCA and ISO 13485 certificates under my remit• Application review of contract, determine audits, assessor competence, and durations needed• Compile submissions to create, modify, suspend, and cancel certiifactes.• Evaluate change notifications • Evaluate Clinical documentation as part of technical document assessments for MDRSkills and Technologies:Scheme Management, Clinical evaluation

Education

• Spokane Falls Community College

  AAS, Hearing Instrument Sciences

  2011 — 2013

• Franciscan School of Theology

  MA, Biblical Languages

  2006 — 2010

• Gonzaga University

  BS, Computer Science

  1998 — 2002