Regulatory Affairs Engineer for Medical 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 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
Additional
- Must have deep familiarity with specific regulatory standards (IEC/EN 60601-1, EN 60335-1, EN 61010-1). Reference code: VA23-03836-MA.
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