Associate Manager Regulatory Affairs (m/w/d)
Biosensors International Group, Ltd · Hechingen, Baden-Württemberg ·
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.
What to expect 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 What you bring along 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