h3Location /h3pMilan or Salerno /ph3Summary /h3pThe Regulatory Affairs Portfolio Manager owns the regulatory strategy and technical file of Newel's medical device software, from classification through to submission and post-market maintenance, and acts as the regulatory partner to internal teams, notified bodies and authorities. /ph3Major accountabilities /h3ulliDefine device qualification, classification and regulatory strategy for each product, and the applicable regulations, tracking their evolution over time. /liliCoordinate the definition of intended use, target population and operating principle (target product profile) with the Product Owner and the Clinical Validation Expert. /liliCoordinate development and maintenance of the technical file, leading reviews and inspection points up to submission to notified bodies and authorities. /liliMonitor the risk-vantaggi profile (safety, performance and clinical benefits) across the product lifecycle, driving risk management according to ISO 14971, including data privacy and cybersecurity risks. /liliLead internal and external qualification and surveillance audits on medical device products. /liliBuild and maintain good relationships with notified bodies, authorities and internal stakeholders. /li /ulh3Key performance indicators /h3ulliRegulatory strategy and device classification defined and kept up to date for each product. /liliTechnical file documents delivered on the agreed submission timeline for all products. /liliBiomarker validation strategy and guidance defined and maintained. /liliInput to the risk management plan, and risk management documents reviewed and kept current. /liliAudit findings closed on time. /li /ulh3Work experience /h3ulliRegulatory work on medical device software (SaMD) under EU MDR, with FDA SaMD exposure.



/liliBuilding and maintaining technical files and leading them through to submission. /liliInteraction with notified bodies and authorities. /liliSupporting product owners in development planning, change evaluation and releases of device versions. /liliLeading or supporting internal and external audits. /liliPartnering with Product, Clinical, Data Science, Engineering, Project Management, COO and Head of Engineering. /liliProviding regulatory guidance and influencing cross-functional decisions. /li /ulh3Skills /h3ulliEU MDR and FDA SaMD experience; IEC 62304, ISO 13485 and ISO 14971. /liliTechnical guidance on SaMD qualification and classification; technical references for the software lifecycle (EN 62304, 82304). /liliAI/ML regulatory guidance (EU AI Act). /liliTechnical file quality and attention to detail. /liliStakeholder management and communication. /liliHandling several products and submissions at once. /liliCompliance mindset and cross-functional collaboration. /li /ulh3Desirable /h3ulliGDPR and health data rules. /liliBiomarker validation strategy and guidance: analytical and clinical validation of digital biomarkers, context of use, regulatory acceptance of the evidence. /li /ulh3Languages /h3ulliEnglish. /liliItalian /li /ulh3Education and qualification /h3ulliDegree in a scientific, engineering or regulatory discipline. /liliRegulatory Experience: 10 years in Medical Devices with minimum 6 years in SaMD. /li /ulh3About Newel /h3pNewel Health is a digital medical device company focused on chronic disease. Born as a spin off from Healthware Group, Newel combines deep digital health roots with a clear mission: to make care more continuous, personal, and effective through regulated, AI enabled digital medical devices. Today, the company operates with certified products, a growing pipeline, and a legal manufacturer model built to scale with partners. /p #J-18808-Ljbffr

📌 Regulatory Affairs Portfolio Manager (Milano)
🏢 Newel Health
📍 Milano