Regulatory Affairs Engineer for Medical Devices and Electrical Engineering | Approbationsingenieur (m/w/d) Medizintechnik und Elektrotechnik
FERCHAU GmbH Niederlassung Mannheim
Job Summary
As a Regulatory Affairs Engineer, you will play a critical role in bringing medical technologies to market by managing the CE conformity assessment process for electrical medical devices. Your day-to-day responsibilities involve ensuring strict compliance with the Medical Device Regulation (MDR) and essential safety standards such as IEC/EN 60601-1. You will organize safety and EMC testing, maintain technical documentation, and collaborate closely with development teams to ensure designs meet regulatory requirements from the start. This role is ideal for a detail-oriented professional who enjoys navigating complex legal frameworks and acting as a bridge between internal engineering teams and external authorities. Joining FERCHAU offers a unique opportunity to work on high-impact projects within the Pharma and Life Science sectors, supported by a comprehensive benefits package including childcare subsidies, professional development programs, and a company pension scheme.
Required Skills
Education
Completed degree in Electrical Engineering, Medical Technology, Mechatronics, or a comparable field of study.
Experience
- Professional experience in the approval, certification, or development of electrical devices
- Proven experience in conducting CE conformity assessments for medical products
- Experience in risk management processes according to EN ISO 14971
- Practical experience in organizing and conducting safety and EMC tests
Languages
Additional
- The role requires a structured way of working and the ability to communicate effectively with external testing centers and regulatory authorities.
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