Combination Device Consultant (524363) Berlin, Germany

• Focusing into AutoInjectors – understanding the design and regulations surrounding Class IIb Devices
• Acting as the SME to ensure that projects can keep to time lines, including being the liaison point between different teams that contribute to Combined Device Production
• Understanding of Engineering and Production to ensure that the Design files are correct under current regulations 
• Working experience with the MDR, ISO 13485, ISO 14971, IEC 60601 (IEC 62304 advantageous not essential)
• FDA audit knowledge including a thorough understanding of 21 CFR part 820
• 20% homeworking flexibility 

• German speaking preferred – English Essential
• Prior experience of working with AutoInjectors essential