Gabriela Marozzini Email & Phone Number

Buenos Aires, Argentina

As the Operations Manager, I am now directly in charge of the Company's Regulatory Affairs Professionals (Project Managers and Client Managers) while maintaining the responsibility for the Project Support Center's tasks and performance. Besides that, I have teamed up with Regulatory Experts and the Licensale 2.0 development task force, to put this new revolutionary tool into action. It is really great to see how my professional evolution and AGCI's success go hand in hand, and I expect to have the honor to lead this exceptional team to the next level.

Buenos Aires, Argentina

The Project Support Center was created to tackle recurrent quality problems in the projects execution. As Project Support Center Manager, I supervised the team responsible to monitor the projects, request corrections and/or corrective actions and execute or take control of special activities. Also, to determine the the system infraestructure and allocate the necessary resources to support our Projects.In addition, I had a major role in the definition and establishment of the policies, processes and SOPs in which operations are based. I progressively moved to a more active role with the Company's Clients and Project Managers, to virtually perform as their direct supervisor.

Buenos Aires, Argentina

- Design of regulatory strategies to obtain medical devices registrations globally. Expertise in Latin-American countries. - Management of projects targeted to obtain sales clearance in different markets (CE, FDA, ANMAT, ANVISA, etc), for clients located worldwide. Oversight of project's financial profiles.- Single contact point in large projects (several countries and/or several products), specially for Clients from the USA, Canada and Europe.- Identification, qualification and supervision of subcontractors, locally and internationally (Brazil, Central America, Colombia, Chile, China, Ecuador, Mexico, Peru, Uruguay).- Point of reference within the Organization for Latin America-related queries- Active participation in the design process of the system used to support the Company's operation.- Direct supervision of two Bioingineers, performing in the Company as Regulatory Affairs Specialists.- Reporting directly to Arazy Group's Chief Operations Officer.

Buenos Aires, Argentina

- Design of regulatory strategies to obtain medical devices registrations globally. Expertise in Latin-American countries. - Project management of projects aimed to obtain sales clearance in different markets (CE, FDA, ANMAT, ANVISA, etc), for clients located worldwide. - Preparation of EC Technical Files and Design Dossiers, FDA 510(k)s and Dossiers for Latin-American markets (Argentina, Brazil, Mexico, Colombia, Peru, etc).- Supervision of subcontractors, locally and internationally (Mexico, Colombia, Brazil, Central-America, China). - Generation and maintenance of a database to characterize the regulatory frame in the region.- Development of Company’s products: preliminary survey, definition and documentation. - Consultancy and technical support to clients, by phone or email, about global medical devices regulations.- Fluent contact with clients and leads, both local and international. Technical assistance to the Company’s account managers, in meetings and preparation of quotations. - In-company and online training to Company’s sales team, in Spanish and English.- Participation in the Group’s booths and technical-commercial meetings in Exhibitions, such as Medica 2011(Dusseldorf, Germany) and Expomedical 2009-2011. In the latter, delivery of lectures on subjects related to the Company’s scope of services.

Oro Verde, Entre Ríos, Argentina

Bioengineer, Bioengineering And Biomedical Engineering

Master Of Business Administration - Mba

Specialist In Management Engineering