Regulatory Affairs Engineer for Medical and Electrical Engineering | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik

Job Summary

As a Regulatory Affairs Engineer, you will play a critical role in ensuring that electrical medical devices meet stringent safety and compliance standards. Your day-to-day responsibilities involve conducting CE conformity assessments and ensuring adherence to the Medical Device Regulation (MDR) and key standards such as IEC/EN 60601-1. You will be responsible for organizing safety and EMC testing, maintaining technical documentation, and contributing to risk management processes according to EN ISO 14971. This role serves as a vital link between the development department and external testing bodies, providing guidance on standard-compliant designs. This position is particularly attractive for professionals looking to work on complex life science projects within a supportive environment that offers comprehensive benefits, including childcare subsidies, company pension schemes, and extensive professional development opportunities.