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

Jobs at Triga Consulting GmbH & Co KG

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