LocationMilan or Salerno

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SummaryThe 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-vantaggi 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

📌 Regulatory Affairs Portfolio Manager (Milano)
🏢 Newel Health
📍 Milano