Baden-Württemberg: REGULATORY AFFAIRS MANAGER (m/f/d) - Medical Device

Overview

Einleitung Our client develops, manufactures and distributes cutting-edge surgical technology worldwide. At its location in the south of Stuttgart, we are currently recruiting for a : REGULATORY AFFAIRS MANAGER (m / f / d) Homeoffice : 50% Details : permanent position - 35 hrs. per week – 35 vacation days per year

Aufgaben

• Preparation and updating of technical documentation for medical devices in compliance with MDR 2017 / 745
• Ensuring compliance with applicable regulatory requirements
• Development of test plans, organization of testing procedures, and definition of test characteristics and equipment
• Creation of standard test reports to demonstrate compliance with relevant norms
• Acting as the main contact for notified bodies during technical documentation reviews and regulatory inquiries from development and production teams
• Defining regulatory strategies for the approval of medical devices

Qualifikation

• A completed degree in engineering or natural sciences
• Professional experience in Regulatory Affairs for medical devices
• Knowledge in the areas of ISO 13485 and MDR
• Excellent German (C1) and English language skills, both written and spoken
• Strong coordination and organizational skills

Benefits

What TRIGA Offers You : New career perspectives and comprehensive consulting for your personal RA career
Positions that match your skills, knowledge, and goals
Exclusive job opportunities with background information about the company
Optimization of your application documents and intensive preparation for interviews
Direct access to decision-makers and negotiation of the best compensation package

Noch ein paar Worte zum Schluss

YOUR CONTACT : Silvio Di Meglio Managing Director at TRIGA Consulting GmbH & Co. KG