Michael Chellson, RAC, serves as the President of Pathways to Success Consulting (P2S), where he leverages his extensive experience in Quality Assurance (QA) and Regulatory Affairs (RA) to drive transformational change within the medical device and pharmaceutical sectors. With a proven track record of managing...
Michael Chellson, RAC, serves as the President of Pathways to Success Consulting (P2S), where he leverages his extensive experience in Quality Assurance (QA) and Regulatory Affairs (RA) to drive transformational change within the medical device and pharmaceutical sectors. With a proven track record of managing multiple global sites, Michael brings a unique global perspective to organizational transformational management, making him an invaluable asset to clients navigating the complexities of regulatory compliance and product development.
At P2S, Michael is dedicated to understanding the nuanced needs of clients, crafting innovative, "out-of-the-box" solutions that facilitate rapid and efficient pathways to success. His expertise spans critical areas such as global management system development and implementation, Lean manufacturing, and validation and verification (V&V) processes. Notably, he has led significant projects, including the strategic implementation of the EU Medical Device Regulation (MDR) for major MedDev and pharmaceutical clients from 2019 to 2020, ensuring compliance while optimizing operational efficiency.
Michael’s skills in automation, software development, and virtual organizational development further enhance P2S's capabilities, allowing the firm to address diverse challenges in manufacturing and post-market follow-up. As a change agent, he thrives in dynamic environments, continuously seeking opportunities to improve processes and drive organizational excellence. His commitment to fostering a culture of innovation and compliance positions P2S as a leader in the consulting space, empowering clients to meet their goals and objectives in an ever-evolving regulatory landscape.