Risk Manager - Medical Devices

Project overview

For a challenging project in the field of medical devices, we are looking for an experienced Risk Manager (m/f/d) as soon as possible.

In this role, you will independently take on operational tasks in the risk management of medical devices and support the continuous maintenance, review, and development of the existing risk management documentation.

Requirements

Completed degree in Medical Technology, Biomedical Engineering, Engineering, Computer Science, Natural Sciences, Medicine, or a comparable field. Several years of practical experience in the risk management of medical devices. Very good knowledge of ISO 14971 and ISO 13485 as well as European regulatory requirements for medical devices. Sound experience in creating and maintaining complete Risk Management Files. Good knowledge of relevant risk management methods, especially FMEA, Hazard Analysis, Fault Tree Analysis, and Benefit-Risk Assessment.

Experience with medical device software (Medical Device Software / SaMD). Knowledge in the areas of Software Safety, Usability Engineering, and Cybersecurity is required. Experience with Post-Market Surveillance, Complaint Handling, and CAPA processes. Independent, structured, and solution-oriented way of working. Strong communication skills and experience in collaborating with international, interdisciplinary teams.

Remote, from 11/16/2026 to 07/12/2027.

Project details

• Start: flexible
• Location: DE
• Languages: German