With PhD’s in Chemistry and Pharmacy, Maria started her career working for two global pharmaceutical companies in various regulatory, quality and production capacities. After 8 years working in OEM Pharma, Maria joined a large Italian Medical Device and Pharma consultancy, where her passion for the registration, market authorization and regulatory strategies for medical devices really started to spark.  She has been an independent consultant since 2020.

With over eighteen years of Regulatory Affairs experience for medical devices and novel products, Maria has worked as a trusted consultant, an EU Authorized Rep & a UK Responsible Person for different size clients across myriad technology platforms. She has spent the past few years working with a variety of manufacturers to obtain their ISO 13485 Certification or to comply with the CE mark and the MDR/IVDR requirements.

Maria specializes in helping medical device manufacturers with their Notified Body relationship and management by providing responses to audit findings, preparing registration documentation, or simply providing direction to move forward with registration. She has extensive experience writing technical documentation for medical devices and invitro diagnostics, as well as clinical evaluations and performance evaluations.

In addition to her work, Maria is proactive in continuing her training to make sure she is up-to-date and knowledgeable on the newest regulations and technologies. She has participated in various training in the United States and Europe. Her most recent training was related to updates in novel medical devices and in vitro diagnostics regulated under MDR 2017/745 and IVDR 2017/746.

Maria was born in Italy but grew up in Buenos Aires. She spent a large part of her young adulthood living in various countries including Italy, Spain, Argentina and the United States. Currently, she is living in Barcelona with her husband.

In her free time, Maria enjoys playing paddleball and cooking, especially her grandmother’s traditional cookie recipe.