Stefan Grigarczik

Background

About Stefan Grigarczik

I believe that the healthcare industry is transforming towards a dual model of fully automated centralized labs and accessible home/self-testing solutions, benefiting both the healthcare system’s efficiency and patient convenience. I’m committed to building the infrastructure needed for this future, embracing new technologies, and taking calculated risks that foster progress. As a leader, I believe in empowering others, drawing on their expertise, and helping them adapt to a fast-evolving regulatory landscape. About Me With over 20 years of experience in software development, project management, and global regulatory affairs within the healthcare and in vitro diagnostics (IVD) industries, I am dedicated to enabling impactful innovations. Currently, as the Global Regulatory Affairs SubChapter Lead for Laboratory Instruments and Software as a Medical Device (SiMD), I lead teams to ensure our products meet the highest standards and regulatory requirements, driving quality and compliance globally. My career has taken me from software development to project leadership and into global regulatory affairs. I started as a software developer, then advanced to Project Leader for Software in IVD Instruments, and later moved into regulatory roles, where I served as a Regulatory Affairs Manager before becoming the Global Functional Lead for Regulatory Affairs in Point of Care. My background equips me with the unique ability to bridge technical and regulatory perspectives, ensuring that our teams meet complex, fast-evolving compliance standards. Regulatory Affairs Expertise - Standards and Compliance: Skilled in IVDD/IVDR, FDA 510(k)/PMA, NMPA, MDSAP, and IMDRF regulatory pathways - Industry Leadership: Active MedTech Europe Delegate, contributing to standards development and best practices Core Skills - Project Management & Design Control: Leading projects that drive quality and efficiency within regulatory frameworks - Quality Management Systems (QMS): Strengthening QMS processes to enhance compliance and operational consistency - Global Team Building: Experienced in setting up cross-functional, continent-spanning teams that align development with regulatory needs Passions and Interests I’m a tech enthusiast at heart, focused on optimizing processes and developing people to make impactful changes. Outside of work, I enjoy family time, coaching Karate Do, and exploring creative pursuits like photography, drone videography, and electronic music production