Regulatory Affair Portfolio Manager

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Company Description Newel Health develops certified digital medical devices that extend care beyond traditional clinical settings, with a focus on chronic conditions such as cardiometabolic disease, Parkinson’s disease, and chronic pain. The company designs, develops, and manufactures Software as a Medical Device (SaMD) solutions that integrate artificial intelligence, behavioral science, clinical evidence, and real-world data to support patients in their daily lives. Its portfolio includes regulated digital solutions for hypertension, chronic musculoskeletal pain, and Parkinson’s disease, helping healthcare partners deliver more personal, measurable, and scalable care. As a SaMD legal manufacturer, Newel Health collaborates with pharmaceutical companies, medtech organizations, and healthcare systems to license products, co-develop companion solutions, build digital endpoints, and create patient support programs with full regulatory accountability from concept to market.

Role Description The Regulatory Affair Manager is a full-time, on-site role based in Milan or Salerno (Italy),



responsible for overseeing regulatory activities across Newel Health’s SaMD portfolio. The role includes interpreting and applying relevant regulatory requirements, defining regulatory strategies, and managing submissions for certifications, approvals, and renewals in target markets. The Regulatory Affair Portfolio Manager will prepare, review, and maintain documentation for regulatory filings, support cross-functional teams in product development and lifecycle management, and ensure compliance with applicable medical device and digital health regulations. This role also involves monitoring regulatory changes, advising internal stakeholders on impact and implementation, and collaborating with external partners and authorities to ensure timely approvals and ongoing conformity.

Major accountabilities
• Define device qualification, classification and regulatory strategy for each product, and

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