Regulatory Affair Portfolio Manager

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 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-benefit profile (safety, performance and clinical benefits) across the product lifecycle, driving risk management according to ISO *, 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.
Minimum requirements
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 internal and external audits.
Partnering with Product, Clinical, Data Science, Engineering, Project Management, COO and Head of Engineering.
Providing regulatory guidance and influencing cross-functional decisions.
Skills
EU MDR and FDA SaMD experience; IEC *, ISO * and ISO *.
Technical guidance on SaMD qualification and classification; technical references for the software lifecycle (EN *, *).
AI/ML regulatory guidance (EU AI Act).
Technical file quality and attention to detail.
Stakeholder management and communication.
Handling several products and submissions at once.
Compliance mindset and cross-functional collaboration.
Desirable
GDPR and health data rules.
Biomarker validation strategy and guidance: analytical and clinical validation of digital biomarkers, context of use, regulatory acceptance of the evidence.
Languages
English.
Italian.
Education and qualification
Degree in a scientific, engineering or regulatory discipline.
Regulatory Experience: 10 years in Medical Devices with minimum 6 years in SaMD.
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