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

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