Johana Ty

Johana Ty is a Regulatory Affairs Manager at Hologic, Inc. since June 2021, managing regulatory activities across multiple sites and ensuring quality compliance through KPI reporting. Key achievements include transitioning Technical Files for IVDR compliance, overseeing international submissions in various regions, and integrating regulatory processes with global standards. Previously, Johana held the role of Regulatory Affairs Manager at Mobidiag, where strategic regulatory compliance was essential for In Vitro Diagnostic medical devices, and served as a Consultant Manager at STRATEGIQUAL SAS, focusing on Quality Management Systems for MedTech startups. Early career experience includes positions at EOS imaging, where Johana worked in quality assurance and regulatory affairs for medical device registrations in the APAC market. Academic qualifications feature a Master's degree in Quality of Health Products with a specialization in Medical Devices from Paris-Sud University and a degree in Clinical Affairs from ISIFC.