À propos de Patricia
I help MedTech startups and innovative healthcare companies turn complex regulatory challenges into clear, actionable, and business-friendly solutions.
Specialized in SaMD, AI-driven medical technologies, CE marking under MDR (EU) 2017/745, and ISO 13485, I support companies from product development to certification readiness and market access.
What makes my approach different is my ability to combine strong regulatory expertise with a deep understanding of software, AI, and fast-moving product development environments. My goal is not only to ensure compliance, but also to make QARA more accessible, pragmatic, and seamlessly integrated into technical workflows, helping teams move fast without slowing innovation down.
I am a really dynamic person, solution-oriented, and deeply involved in the projects I support. I enjoy working as a true partner alongside founders, product teams, and QARA departments to help innovative healthcare technologies successfully reach the market.
Français
Bilingue ou natif
Anglais
Bilingue ou natif
En télétravail uniquement
Travaille majoritairement à distance
Expériences
- Brainquant SAHead of QARAHIGH TECHseptembre 2025 - Aujourd'hui (9 mois)Paris, France
- Leading regulatory and quality activities for AI-driven Software as a Medical Device (SaMD) solutions in the field of neuroimaging and brain MRI analysis.
- Leading CE marking strategy, technical documentation development, and compliance with MDR (EU) 2017/745, ISO 13485, IEC 62304, and ISO 14971 requirements.
- Managing and structuring the company’s Quality Management System (QMS) and regulatory processes from scratch
- Contributing to software lifecycle documentation, risk management and verification & validation strategies.
- Acting as a bridge between regulatory, technical, and product teams to facilitate compliant and efficient product development.
- Performing audit preparation, certification activities, and interactions with external stakeholders including Notified Bodies and regulatory partners.
- HCK Healthcare Konnect SAHead of QARAHIGH TECHseptembre 2025 - Aujourd'hui (9 mois)Paris, France
- Leading Quality Assurance & Regulatory Affairs activities for the company, including Quality Management System (QMS) maintenance and regulatory compliance oversight.
- Managed the implementation, structuring, and successful certification of the company’s Information Security Management System (ISMS) according to ISO 27001.
- Overseeing regulatory and quality processes related to digital health and medical device software distribution
- Coordinating cross-functional teams to ensure quality, cybersecurity, and regulatory requirements are efficiently integrated into operational workflows.
- ApnealQuality and Regulatory Affairs ManagerHIGH TECHoctobre 2022 - mai 2025 (2 ans et 7 mois)Paris, France
- Led the regulatory and quality strategy for a Software as a Medical Device (SaMD) dedicated to sleep-related breathing disorder assessment.
- Implemented the Quality Management System (QMS) in compliance with ISO 13485 and MDR (EU) 2017/745 requirements - ISO 13485 certification obtained
- Created the technical file and associated documentation including intended use, software documentation, risk management files, usability engineering.
- Contributed to the regulatory positioning and compliance strategy of AI-driven and software-based medical device functionalities.
- Coordinated cross-functional activities with software, clinical, and product teams to ensure regulatory alignment throughout the development lifecycle.
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Formations
- Master Qualité Sécurité Environnement, Domaine Sciences, technologies, santé Mention QUALITE, HYGIENE, SECURITE INSTITUT FRANCILIEN D'INUniversité Paris-Est Marne-la-Vallée2017Master Qualité Sécurité Environnement, Domaine Sciences, technologies, santé Mention QUALITE, HYGIENE, SECURITE INSTITUT FRANCILIEN D'IN
- Licence, Sciences et Technologie - Option Sciences du vivantUniversité Pierre et Marie Curie (Paris VI)2015Licence, Sciences et Technologie - Option Sciences du vivant