Jennifer Harris

Jenny is a seasoned leader in Quality Assurance and Regulatory Affairs (QA/RA) with over 30 years of experience in driving compliance, strategic operations, and process improvements within the medical device industry. She has played a pivotal role in ensuring business growth and leading global Quality Management System initiatives in progressively senior roles.  

Most recently Jenny served as the Senior Director of Regulatory Affairs and Quality Assurance for Hyperfine, driving strategic oversight for quality and regulatory operations by guiding new product development and compliance efforts. In this role, she served as the organization’s QA/RA Management Representative leading the implementation of efficient processes to support complex electromechanical medical devices with AI-enabled software.  

Prior roles include leadership positions at Osteomed/Acumed, Stryker Communications, and Siemens where she led QA/RA teams, spearheaded quality system improvements and managed regulatory strategies and inspections. Jenny’s experience includes oversight of all aspects of quality management across multiple jurisdictions. Additionally, she has directed post-acquisition quality system consolidation and led Lean Management principle initiatives. She has built a reputation as a transformational leader, mentoring teams, driving efficiency, and ensuring organizations maintain a state of perpetual inspection readiness. Jenny currently serves as the VP of Quality and Regulatory for HOPPR.