Professional Experience 

• Development and conduct of training for Clinical Investigations, Medical Devices and regulatory aspects, in-house and for clinical research staff 
• Conduct of Clinical Investigations according to Medical Device Regulations and EN ISO 14155 in various European countries 
• Staff responsibility in an internationally operating medical device company, staffing of clinical projects according to milestones and quality standards, staff development and coaching  
• Vendor selection for Medical Device Clinical Investigations, contract negotiations, contract management 
• Project management, budgeting, development of study concepts in collaboration with Key Opinion Leaders, marketing and regulatory departments 
• Dossier preparation and submission to Ethics Committees, Competent Authorities and other regulatory agencies (i.e.Bundesamt für Strahlenschutz) 
• Medical writing: Clinical Investigational Plan (Protocol), Patient Informed Consent, Case Report Form, Reports and Publications, Guidelines, Procedures 
• Monitoring according to regulations, international quality standards and company SOPs 
• Languages: German native speaker, English – excellent verbal and written communication