Location Milan or Salerno Summary The 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. Major accountabilities * Define device qualification, classification and regulatory strategy for each product, and the applicable regulations, tracking their evolution over time. * Coordinate the definition of intended use, target population and operating principle (target product profile) with the Product Owner and the Clinical Validation Expert. * Coordinate development and maintenance of the technical file, leading reviews and inspection points up to submission to notified bodies and authorities. * Monitor the risk-agevolazioni profile (safety, performance and clinical benefits) across the product lifecycle, driving risk management according to ISO 14971, including data privacy and cybersecurity risks.



* Lead internal and external qualification and surveillance audits on medical device products. * Build and maintain good relationships with notified bodies, authorities and internal stakeholders. Key performance indicators * Regulatory strategy and device classification defined and kept up to date for each product. * Technical file documents delivered on the agreed submission timeline for all products. * Biomarker validation strategy and guidance defined and maintained. * Input to the risk management plan, and risk management documents reviewed and kept current. * Audit findings closed on time. Work experience * Regulatory work on medical device software (SaMD) under EU MDR, with FDA SaMD exposure. * Building and maintaining technical files and leading them through to submission. * Interaction with notified bodies and authorities. * Supporting product owners in development planning, change evaluation and releases of device versions. * Leading or supporting in

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