Advisor Regulatory Affairs/Quality Management for medical devices

We are looking for an Advisor Regulatory Affairs for medical devices to further expand our young, dynamic Medical Devices team, to start at the earliest possible opportunity.

Your tasks:

• Coordination of all necessary activities regarding the legally compliant CE marking of medical devices
• Preparation and reviewing of technical documentation and summary technical documentation
• Activities regarding the fulfilment of international regulatory requirements for medical devices
• Implementation and support for the introduction of quality management systems, including preparation of procedure/work instructions, analysis and assesment of existing and newly implemented process and procedures
• Independent project management
• Consulting for customers, conduct of in-house training and moderation for customers
• Development and expansions of positive collaboration with customers, authorities and cooperation partners

Your profile:

• Degree in engineering or natural sciences, ideally with PhD
• Very good knowledge of regulatory matters regarding medical devices 
  (e.g. medical device standard ISO 13485) and several years of 
  professional experience in the field of regulatory affairs or quality 
  management
• Goal orientation, dedication, flexibility, capacity for teamwork and entrepreneurial thinking
• Sound user knowledge of MS Office
• Excellent command of (spoken and written) German and English
• Willingness to work on customers' premises, advisor personality