Regulatory Affairs Portfolio Manager - SaMD (EU/FDA)

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

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.