Barbara Baruzzo

Background

About Barbara Baruzzo

With over 25 years of experience in the medical device industry, I have built a strong foundation in Quality Assurance and Regulatory Affairs. From CE Marking to FDA submissions, I have successfully navigated complex regulatory environments, ensuring compliance with global standards such as ISO 13485, MDR, and 21 CFR 820. My professional journey has included leadership roles where I’ve developed and implemented quality management systems, led regulatory strategy planning, and coordinated audits and inspections. I am known for my structured approach, attention to detail, and ability to translate regulatory requirements into clear operational processes. What drives me is the opportunity to contribute to the safety and effectiveness of life-saving technologies, and to work with cross-functional teams that share a passion for innovation and quality. I believe in continuous learning, adaptability, and in the power of collaboration to overcome challenges.