Regulatory Affair Portfolio Manager

Newel Health Srl; Lombardia; On-site; EUR 70,000 - 100,000; Full time

Job summary

Newel Health Srl in Italy is seeking a Regulatory Affairs Manager to oversee regulatory activities for its SaMD portfolio. The role is full-time and on-site in Milan or Salerno, reporting to the head of Regulatory Affairs.

You will define product classification and regulatory strategies, coordinate technical files, manage submissions to notified bodies and authorities, and monitor lifecycle regulatory changes across markets.

Qualifications

• 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.

Responsibilities

• Define device qualification, classification and regulatory strategy for each product.
• Coordinate intended use, target population and operating principle with Product Owner and Clinical Validation Expert.
• Coordinate development and maintenance of the technical file, leading reviews and submission readiness for notified bodies.
• Monitor the risk-benefit profile across the product lifecycle, including data privacy and cybersecurity risks.
• Lead internal and external audits and surveillance activities.
• Build and maintain good relationships with notified bodies, authorities and internal stakeholders.

Skills

EU MDR expertise

FDA SaMD exposure

Technical file management

Stakeholder management

Audits & inspections

Regulatory strategy

Cross-functional collaboration

Regulatory guidance

ISO 14971 risk management

IEC 62304 / ISO 13485

SaMD regulatory knowledge

Education

Science/Engineering/regulatory degree

Job description

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 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.

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 62304, ISO 13485 and ISO 14971.
• Technical guidance on SaMD qualification and classification; technical references for the software lifecycle (EN 62304, 82304).
• 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.