About the Position

Regulatory Affairs Portfolio Manager

Newel Health is seeking a Regulatory Affairs Portfolio Manager to oversee the regulatory strategy and technical file for our medical device software in Milano, Italy.

Responsibilities

Define device qualification, classification, and regulatory strategy for each product, and track their evolution over time.
Coordinate the definition of intended use, target population, and operating principle 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.

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.

Nice to Have

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 a minimum of 6 years in SaMD.

We Offer

Competitive salary
Opportunity to work in a dynamic and innovative environment
Professional growth and development opportunities

About the Company

Newel Health

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. Today, the company operates with certified products, a growing pipeline, and a legal manufacturer model built to scale with partners.

Location

Milano, Milano, Italy

Employment Type

Permanent

Minimum Experience

Experienced

NEWEL HEALTH

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Regulatory Affairs Portfolio Manager

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