19 ott - Italia
Newel Health
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 (Sa MD) under EU MDR, with FDA Sa MD 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. Pa
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