Risk Manager Medical Devices

Project overview

Your Activities

For a demanding project in the medical device sector, we are looking for an experienced Risk Manager (m/f/d) as soon as possible. In this role, you will independently undertake operational tasks in the risk management of medical devices and support the continuous maintenance, review, and further development of existing risk management documentation. The tasks include in particular:

The Profile Sought

Language Requirements

• Independent execution and further development of risk management according to ISO 14971 and ISO 13485.
• Creation, revision, and maintenance of Risk Management Plans, Risk Analyses, Risk Evaluations, and Risk Management Reports.
• Execution of hazard analyses as well as risk assessments and risk evaluations within the scope of product development and product changes.
• Identification, assessment, and documentation of hazards and risks related to medical device software and SaMD.
• Definition and evaluation of suitable risk control measures and verification of their effectiveness.
• Evaluation of complaints, incidents, CAPA measures, and Post-Market Surveillance data regarding possible impacts on the risk profile of the products.
• Execution of gap analyses of existing risk management files and derivation of concrete optimization measures.
• Ensuring complete traceability between hazards, risks, risk control measures, and verification evidence.
• Cross-functional collaboration with Regulatory Affairs, Quality Management, Product Management, Development, and Clinical Evaluation.
• 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 the creation and maintenance of 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.
• German: Fluent
• English: Advanced knowledge

Project details

• Start: 2026-11-16
• Duration: 16.11.2026 - 12.07.2027
• Remote: remote
• Location: DE
• Languages: German, English