Monica Marini

Regulatory Affairs & Clinical Research Manager at Asensus Surgical

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.

Links

Previous companies


Org chart


Teams

This person is not in any teams


Offices

This person is not in any offices


Asensus Surgical

2 followers

Asensus Surgical is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery™ by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery.


Industries

Employees

51-200

Links