Location

Milan or Salerno

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.

About the role

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.

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

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