Regulatory Affairs Portfolio Manager
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. 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 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. Desirable
* 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 minimum 6 years in SaMD. About Newel 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. #J-18808-Ljbffr
* 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 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. Desirable
* 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 minimum 6 years in SaMD. About Newel 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. #J-18808-Ljbffr