Senior Consultant – Regulatory Affairs, Medical Devices, Software, AI

• Develop regulatory approval strategies for medical devices and IVDs in the EU, the USA, and international markets
• Support the approval of medical devices, including software as or in a medical device (SaMD / SiMD) and AI-based functions
• Translate regulatory requirements into concrete next steps for Regulatory Affairs, Development, Quality Management, and Product Management
• Prepare and review technical documentation and regulatory submission dossiers
• Assess products, product changes, and new technologies with regard to qualification, classification, regulatory pathways, and regulatory requirements
• Communicate with notified bodies, authorities, and other stakeholders
• Guide clients through complex coordination and consultation processes
• Independently take responsibility for consulting projects and ensure their successful completion

• Completed degree, for example in a natural science, technical, medical, or engineering discipline
• At least five years of professional experience in Regulatory Affairs for medical devices
• Knowledge of the regulatory requirements under the MDR and FDA regulations
• Understanding of how software is developed, documented, and regulated
• Interest in AI technologies and willingness to explore their application in medical devices and the resulting regulatory issues
• Familiarity with ISO 13485, ISO 14971, and IEC 62304
• Fluency in written and spoken German and English
• Willingness to travel occasionally for client projects

• Innovative working environment with plenty of scope for initiative and the freedom to drive change
• Great team atmosphere and strong sense of collaboration
• Support for and encouragement of your professional and personal development
• Flexible working arrangements with no core hours
• Remote work or work from our locations in Konstanz or Frankfurt
• JobRad bicycle leasing program
• Hansefit corporate fitness program
• Two team events per year
• Opportunity to work from another location for a limited period (workation)