ANTON HÜBNER GmbH & Co. KG - A company of the DERMAPHARM Group · Hochschule Pforzheim - Gestaltung, Technik, Wirtschaft und Recht
Regulatory Affairs Manager with a focus on substance-based medical devices under the EU MDR. My current responsibilities include risk management according to ISO 14971, usability engineering according to IEC 62366, change control coordination and regulatory support for MDR certification processes. I support lifecycle-related regulatory activities, including risk management documentation, usability documentation, change control follow-up, notified body interactions and audit preparation. I have supported audits with notified bodies, including representing risk management topics, and I am currently expanding my qualification as an internal auditor.
Risikomanagement Produktion: Erstellung von PRAs sowie P-FMEAs. Moderation von Meetings und Produktionsbegehungen Pflege von Trackinglisten
In der Arbeitsabteilung ,,Nachhaltige Produktentwicklung" angestellt. Unterstützung MaReK - ,,Markerbasiertes Sortier- und Recyclingsystem für Kunststoffverpackungen"
Erwerb der Fachhochschulreife