Location

Milan or Salerno

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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 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.

About Newel

Newel 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. xysqume 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