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

FERCHAU GmbH Niederlassung Mannheim

Bensheim, Hessen, Deutschland
Published Apr 17, 2026
Full-time
No information

Job Summary

As a Regulatory Affairs Engineer, you will play a critical role in ensuring the market readiness of electrical medical devices. Your day-to-day responsibilities include conducting CE conformity assessments, ensuring strict adherence to the Medical Device Regulation (MDR), and managing technical documentation. You will serve as a technical bridge, organizing safety and electromagnetic compatibility (EMC) tests while collaborating closely with development teams to ensure standards-compliant designs. This role is highly collaborative, involving frequent communication with external testing centers and regulatory authorities. The position is ideal for professionals who enjoy high-stakes technical compliance and risk management within the Life Science sector. Joining FERCHAU offers a unique opportunity to work on complex development projects for prestigious clients, supported by a robust benefits package including childcare subsidies, professional development programs, and a comprehensive company pension scheme.

Required Skills

Education

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 managing technical documentation according to MDR requirements
  • Practical experience in organizing and conducting safety and EMC testing
  • Experience in risk management processes specifically for medical technology
  • Experience in communicating with external testing laboratories and regulatory bodies

Languages

German (Fluent)English (Basic)

Additional

  • Must have deep familiarity with specific regulatory standards (IEC/EN 60601-1, EN 60335-1, EN 61010-1). Reference code: VA23-03836-MA.