Regulatory Affairs SaMD Portfolio Manager

Newel Health Srl; Lombardia; On-site; EUR 110,000 - 140,000; Full time

Job summary

Newel Health Srl seeks a Regulatory Affairs Portfolio Manager to own regulatory strategy and the technical file for our medical device software, from classification through submission and post-market maintenance.

You will partner with internal teams, notified bodies and authorities, ensuring compliance across EU MDR and FDA SaMD frameworks while coordinating audits and risk management.

Qualifications

• 10 years in Medical Devices regulatory work with at least 6 years in SaMD.
• Build and maintain technical files and lead submissions.
• Interact with notified bodies and authorities to secure approvals.
• Guide cross-functional teams on development planning and releases.

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.
• Lead the development and maintenance of the technical file through submission.
• Monitor risk-benefit across the lifecycle, addressing ISO 14971, data privacy and cybersecurity.
• Lead internal and external audits of medical device products.
• Build strong relationships with notified bodies, authorities and stakeholders.

Skills

Regulatory strategy

Risk management

Audits

Stakeholder management

SaMD regulatory experience

EU MDR & FDA SaMD

Education

Degree in scientific, engineering or regulatory discipline

Job description

Newel Health Srl seeks a Regulatory Affairs Portfolio Manager to own regulatory strategy and the technical file for our medical device software, from classification through submission and post-market maintenance.

You will partner with internal teams, notified bodies and authorities, ensuring compliance across EU MDR and FDA SaMD frameworks while coordinating audits and risk management.