Regulatory Affairs Specialist

vor 3 Wochen

Munich, Deutschland EPM Scientific Vollzeit

Regulatory Affairs Specialist - Medical Device Manufacturing Project (Bavaria 🇩🇪)We're hiring Regulatory Affairs Specialists for a major medical device manufacturing project based in Bavaria Join a leading Medical Device Company in a hybrid role supporting regulatory submissions, compliance activities, and alignment with EU and international medical device regulations.📍 Location: Bavaria (hybrid) 📅 Duration: 12-month contract 🚀 Start: ASAP🔍 Key Requirements:Proven experience in regulatory affairs within medical equipment manufacturing companiesStrong knowledge of EU MDR, ISO 13485, and familiarity with FDA 21 CFR Part 820 is a plusSkilled in preparing and reviewing technical documentation, regulatory submissions, and supporting Notified Body interactionsDetail-oriented, proactive, and collaborative professionals preferredIf you're available and interested, please send your CV along with your availability. First batch of submissions goes out today 📤

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