Über Ilaria
I help MedTech teams turn complex science and engineering into clear, compliant, and future-ready regulatory systems.
With a background in neuroscience, biomedical engineering, and regulatory affairs, I work at the intersection of science, regulations, and AI-enabled workflows. I specialize in translating technical innovation into structured documentation, risk management strategies, and audit-ready quality systems aligned with EU MDR, ISO 13485, ISO 14971, and digital health requirements.
What makes me different is the ability to bridge disciplines that often struggle to communicate with each other: researchers and regulatory teams, engineers and quality systems, innovation and compliance, human expertise and AI tools.
I typically support projects involving:
• ISO 13485 Quality Management Systems
• Technical Documentation & DHF
• Risk Management & CAPA
• Clinical Evaluation (CEP/CER)
• AI-assisted regulatory workflows
• Digital Health & SaMD environments
I enjoy building structure in fast-moving environments where scientific rigor, emerging technologies, and regulatory expectations need to evolve together.
Italienisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher
Deutsch
Grundkenntnisse
Vor Ort möglich
Basel (bis zu 50 km)
Projekt- und Berufserfahrung
- CNS Therapy / OrthoSensQuality Manager & Regulatory Affairs SpecialistJanuar 2023 - Heute (3 Jahre und 5 Monate)Delémont, JU, SwitzerlandBuilding and operating a full ISO 13485-compliant QMS in a pre-market environment, with direct ownership of the following domains:Quality Management System– Established and continuously improve an ISO 13485-certified QMS, including SOP framework, training logs, and document control infrastructure.– Lead end-to-end change control lifecycle — from initiation and impact assessment through to regulatory documentation updates.– Manage deviation handling and coordinate CAPA processes, ensuring timely resolution, root-cause documentation, and effectiveness verification.Technical Documentation & Regulatory Submissions– Author and maintain MDR-compliant Technical Files and Design History Files (DHF) for devices in development targeting CE marking.– Prepare and maintain risk management documentation per ISO 14971 , including hazard identification, risk estimation, and residual risk evaluation.– Support regulatory documentation and submissions for Swiss (Swissmedic), EU, and US markets, adapting content to jurisdiction-specific requirements.– Develop Clinical Evaluation Plans (CEP) and contribute to Clinical Evaluation Reports (CER), ensuring structured literature-based evidence.Notified Body & Audit Engagement
- University Hospital BaselScientific CollaboratorJanuar 2022 - August 2022 (7 Monate)Basel, Switzerland– Analysed clinical datasets supporting translational research projects in a structured, documentation-driven environment.– Contributed to clinical evidence synthesis relevant to regulated medical contexts.
- University of BaselResearch AssistantJanuar 2018 - Januar 2022 (4 Jahre)Basel, Switzerland– Conducted neuroscience research with rigorous documentation and data management protocols aligned with academic regulatory standards.– Presented findings at international academic and clinical conferences, developing structured communication of scientific evidence.
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Ausbildung und Abschlüsse
- AI Tools & Applied Tech | Agile Working Methods | Business Simulation — xMBA CertificationISA Zurich2026AI Tools & Applied Tech | Agile Working Methods | Business Simulation — xMBA Certification