Monica Marini

Monica Marini is an experienced professional in regulatory affairs and clinical research, currently serving as Ambassador Lombardia at Donne 4.0 since April 2025 and as a Regulatory Affairs & Clinical Research Manager at Asensus Surgical since May 2019. Monica's expertise includes the redaction and maintenance of Technical Documentation in compliance with MDR 2017/745, managing relationships with Notified Bodies, overseeing change assessments, and leading post-market activities. Additional responsibilities involve coordinating clinical evaluation plans and international registrations, supervising a team of regulatory affairs specialists, and managing clinical research efforts for label expansions. Prior experiences include roles at Medtronic, Copan Group S.P.A., Business Integration Partners, and Xpand Biotechnology, complemented by a strong educational background in Biomedical Engineering from Politecnico di Milano and other prestigious institutions.