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 *****, 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 *****, ISO ***** and ISO *****.
/liliTechnical guidance on SaMD qualification and classification; technical references for the software lifecycle (EN *****, *****).
/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.
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📌 Regulatory Affairs Portfolio Manager (Milano)
🏢 Newel Health
📍 Milano