Associate Manager Regulatory Affairs; m​/w​/d

We are looking for a highly qualified and motivated Associate Manager Regulatory Affairs to join our dynamic team (temporary position to cover parental leave) in the medical device industry. In this position you will play a key role in the approval of our products in new countries, the submission and updating of all technical documentation and in the monitoring of standards.

• Support in the creation and management of processes related to regulatory activities
• Support in the preparation of approval / technical documentation for our medical devices
• Collaboration on product approvals for medical devices and their maintenance
• Varied and cross-departmental collaboration on projects for the development of innovative medical devices on the structural heart field
• Monitoring the relevant regulatory intelligence by researching, summarizing, and evaluating regulatory requirements for medical devices as well as informing the appropriate stakeholders in the organization
• Close technical cooperation with internal departments (e.g. development department, project management, quality department) and contact with external partners

• Studies in the field of medical technology, natural sciences or technology
• Curiosity and passion in the field of medical technology
• Experience in the field of regulatory affairs (EU and RoW) – at least 3 years
• Knowledge of regulatory requirements for medical devices (e.g. MDR) or biological materials desirable
• Understanding the basics related to quality assurance, development, or clinical affairs of medical devices is an advantage
• Very good written and spoken English skills
• Structured, accurate and responsible way of working