Job Description

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