Regulatory Affairs Training – Medical Writing

• Training in regulatory fundamentals and the professional preparation of medical and scientific texts
• Training in the fundamentals of medical technology and product development
• Training in Regulatory Affairs, the EU Medical Device Regulation (MDR), and approval procedures
• Training in international approval procedures for the United States, Asia, and Latin America, as well as MDSAP
• Preparation of medical and regulatory texts during a practical training phase
• Individual feedback from experienced instructors
• Training in Medical Writing, quality management, risk management, clinical evaluation, and clinical studies
• Training in technical documentation, project management, innovation and development processes, and Post-Market Surveillance
• Virtual live classes Monday through Friday from 8:30 a.m. to 3:30 p.m. over 3 weeks, or 15 days
• Preparation for entry-level and specialist roles in Regulatory Affairs, regulatory submissions management, quality management, Clinical Affairs, and Medical Writing

• University degree in Life Sciences, Engineering, Informatics, or a related field, or several years of professional experience
• German and English language skills at B2 level (language proficiency is mandatory)
• Formal eligibility requirements for funding through the Federal Employment Agency or Jobcenter must be met

• 100% funding through an education voucher issued by the Federal Employment Agency or Jobcenter
• Career and one-to-one coaching
• Practice-oriented course structure with a strong focus on hands-on training
• Individual support and personal coaching
• Virtual classrooms and workspaces
• Excellent preparation for entering the profession
• Certificate of participation covering all course content upon successful completion
• Work samples upon successful completion