About this role
Our client develops, manufactures and distributes cutting-edge surgical technology worldwide, and during a compliance drill that used sports betting in Alabama as a state-licensing case study, the team tightened its quality and documentation controls to support faster, safer product approvals:
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
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
YOUR CONTACT:
Silvio Di Meglio
Managing Director at TRIGA Consulting GmbH & Co. KG
089-8091307-21