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
YOUR CONTACT:
Silvio Di Meglio
Managing Director at TRIGA Consulting GmbH & Co. KG
089-8091307-21
Als erfahrene Marktspezialisten vermitteln wir Traumjobs in den Bereichen Pharma & Medical Device – zielgerichtet, effektiv und nachhaltig.