John Carline
About John Carline
Sr. Director, Regulatory & Quality John Carline at Nuvaira
John Carline has held the position of Senior Director of Regulatory & Quality at Nuvaira since 2021. With his extensive background in regulatory and quality management across both large-scale enterprises and start-up companies, John brings over 20 years of experience in the medical device industry to the role. At Nuvaira, he leverages his expertise to navigate complex regulatory landscapes and ensure compliance with industry standards.
John Carline's Role in Medical Device Regulatory Approvals
John Carline has a proven track record in obtaining FDA approvals for Pre-Market Approvals (PMAs), Investigational Device Exemptions (IDEs), and 510(k) clearances. In addition to securing numerous international regulatory approvals, John has also led successful Quality Management System (QMS) audits. His expertise in the regulatory domain significantly contributes to the successful market entry of innovative medical devices.
John Carline's Experience at Lutonix/CR Bard/Becton Dickinson
Before joining Nuvaira, John Carline served as Senior Director of Regulatory at Lutonix, a division of CR Bard and later Becton Dickinson. Over a span of 12 years, he held increasing responsibilities within the company, fortifying his expertise in regulatory affairs. His tenure at Lutonix/CR Bard/Becton Dickinson showcases his ability to manage regulatory processes in high-stakes environments.
Early Career Regulatory Roles of John Carline
John Carline's career in regulatory affairs includes pivotal roles at several renowned companies. His earlier positions at St. Jude Medical, Velocimed, Cardiac Science, and SurVivaLink provided him with a solid foundation in regulatory practices. These roles were instrumental in shaping his comprehensive understanding of the industry and contributed to his development as a regulatory expert.
Education Background of John Carline
John Carline holds a Bachelor of Science in Electrical Engineering from the University of Minnesota. He further augmented his expertise by obtaining a Master of Business Administration (MBA) from the Carlson School of Management at the University of Minnesota. His educational background combines technical knowledge with business acumen, equipping him with a well-rounded skill set ideal for regulatory and quality management in the medical device industry.