Associate Director Global Regulatory Affairs, Diagnostics and Digital Health
Johnson and Johnson, United States
Marina holds PhD in Biology and has over 16 years of Regulatory Affairs and Quality Assurance experience evenly divided between Medical Devices and IVDs. She has hands-on experience on ISO 13485, ISO 14971, complaints handling, vigilance, US export controls, EMEA Regulatory Requirements, CE marking, SaMD, Companion Diagnostics and Combined Trials. Marina is currently working as an Associate Director Global Regulatory Affairs, Diagnostics and Digital Health at Johnson and Johnson, acting as an EMEA Regulatory Lead on number of precision medicine development programs in close collaboration with IVD/CDx manufacturers, where she supports with her Regulatory expertise on the IVDs.
Marina is also an active member of MedTech Europe trade association and in the leadership team of the Belgian RAPS Local Networking Group.
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Tuesday, May 13, 2025
08:30 - 16:00 CEST