Florence, Tuscany, Italy
Regulatory Affairs executive with over a decade of experience leading global regulatory strategies for complex healthcare products across the EU, US, and emerging markets. Proven track record in directing high-stakes submissions, aligning regional execution with global strategy, and ensuring compliance in highly regulated environments. I specialize in end-to-end regulatory project leadership from early development through approval and lifecycle management. My work has spanned advanced medical technologies, including AI-enabled devices and software as a medical device, contributed to European standards (CEN/CENELEC JTC 21) and served as a strategic liaison between global teams and regional stakeholders. Throughout my career, I’ve: - Led the preparation and delivery of regulatory dossiers - Owned regional regulatory strategy and execution, ensuring alignment with global plans and local market needs - Mentored regulatory professionals and led process improvements to enhance efficiency and compliance - Championed regulatory agility in response to evolving frameworks, including the EU AI Act and MDR I bring a disciplined, collaborative approach to regulatory leadership, and am focused on delivering patient access, maintaining compliance, and enabling innovation through clear strategy and cross-functional alignment.
Founded Dutch school in Italy, publicly funded since 2012, associated with Stichting NOB (http://www.stichtingnob.nl).
Set up a solid and leveled software architecture, designed a complete development and release lifecycle, in order to be able to respond to international norms and regulations (e.g. FDA, Italian law for measuring instruments) for the use of high precision diagnostic instruments, including a stress on Test Driven Development and including Acceptance test and issue tracking system. Architecture of highly accessible interface infrastructure. Competences Process structuring and coordination; Negotiation for IHE adoptance for ESCRS Key assets Consultancy and knowledge sharing for Eyecare Connect-a-Thon participation with Acquisition Modality Preparation and design for Acquisition Modality, Image Display, Evidence Document Creator Design of MOC course for maintenance dept. Implementation of Agile™ developing approach Certification Prince2® Foundation Courses October 2007 – Introduction to the European Medical Device Directive 93/42/CEE and subsequent European norm UNI EN ISO 14971:2000 November 2007 – System quality management according to 9001:2000 standard and 13485:2004 May 2013 - 14971:2012 and 13485:2012 May 2014 - 60601 3rd edition
Product manager for two of Rasna’s main product lines. One is a DICOM-compliant XML enhancement for storage and representation of DICOM structured reports, the standard for health information, electronic health records. DICOM is the ubiquitous standard for the exchange of images and image related information in the radiology and cardiology imaging industry. The other is a DICOM supportive communication mechanism, applied in the so-called ‘tele-radiology’. Since Rasna’s main customers are resellers, a lot of negotiation and structuring of the implementation had to be done. Through ongoing project designing we managed not only to keep customers happy, but guarantee also product compliance to the latest IHE standards. Competences Project design (using both Microsoft Visio as Rational Rose); Process structuring and coordination; SWOT analysis Key assets Assistance and consultancy for Connect-a-Thon 2008 participation with XDS.a Document Source / Consumer, ATNA and CT Extension for the XML-DICOM broker to include HL/7 parsing IHE Connectathon 2006 participation and preparation for the following integration profiles: XDS, XDS-I and ATNA; Successful implementation in Norway’s health system for the eastern region (Helsenett Est); IHE Connectathon 2005 preparation and partecipation for XDS solution RSNA 2005 preparation of the main product line; UKRC 2004 implementation for Ferrania Imaging Systems.
The SISS (Socio Sanitarian Information System) project of the region of Lombardy is a region wide distributed information management project for the health system. Enhanced with the use of smartcards it is pointed at the controlled information flow between various health instances, as medical specialists, drugstores, first aid desks, etc. In this project I was assigned the flow control of central services in the SISS project. I was responsible for the architectural design of modules for patient registration and privacy control. My work included head responsibility of software development for this division, management reporting and quality testing. Competences Project design and code generation (using both Microsoft Visio as Rational Rose); Process structuring and coordination Benchmark testing Key assets The successful implementation (dec. 2002) of the privacy control service; The successful implementation (apr. 2003) of Notification service in case of a first aid event http://www.regione.lombardia.it