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

Triga Consulting GmbH & Co KG; Tübingen; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

A leading surgical technology company near Tübingen is seeking a Regulatory Affairs Manager (m/f/d). In this permanent, 35-hour per week role, you'll prepare technical documentation, ensure compliance with regulations, and liaise with notified bodies. Ideal candidates will have a degree in engineering or natural sciences, professional experience in Regulatory Affairs, and excellent German and English skills. This position offers 50% home office flexibility.

Leistungen

New career perspectives

Optimization of application documents

Exclusive job opportunities

Qualifikationen

• Experience in the areas of ISO 13485 and MDR.
• Preparation and updating of technical documentation for medical devices.

Aufgaben

• Ensuring compliance with applicable regulatory requirements.
• Development of test plans and organization of testing procedures.
• Acting as the main contact for notified bodies during technical documentation reviews.

Kenntnisse

Professional experience in Regulatory Affairs for medical devices

Excellent German (C1) and English language skills

Strong coordination and organizational skills

Ausbildung

Completed degree in engineering or natural sciences

Jobbeschreibung

Our client develops, manufactures and distributes cutting-edge surgical technology worldwide.
At its location close to TÜBINGEN, 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