Professional Risk Manager Medical Devices

Project overview

For our client, we are looking for an experienced Professional Risk Manager Medical Devices.

You will support medical risk management throughout the entire product lifecycle and independently handle defined tasks within the given processes and approval structures.

Framework Conditions

• Period: 16.11.2026 to 12.07.2027
• Scope: approx. 200 hours, flexible as needed
• Location: fully remote within the EU or EEA
• Contract Type: Freelance

Responsibilities

• Review, maintenance, and further development of the risk management process for medical devices according to ISO 14971 and ISO 13485
• Creation and maintenance of risk management plans, risk analyses, risk assessments, and risk management reports
• Execution and documentation of benefit-risk assessments and ensuring traceability
• Support in the development of new products and in changes to existing medical device software
• Identification of hazards and assessment and evaluation of the resulting risks
• Development of suitable risk control measures
• Evaluation of product changes, customer feedback, complaints, incidents, and post-market surveillance data
• Consideration of CAPA activities, cybersecurity information, and field experience in the risk profile
• Verification of the implementation and effectiveness of risk control measures
• Documentation of residual risks and assessment of their acceptability
• Identification of gaps, inconsistencies, and missing traceability in existing risk management files
• Development of prioritized and actionable improvement suggestions
• Collaboration with Regulatory Affairs, Quality Management, Product Management, Development, Clinical Evaluation, and Post-Market Surveillance

Requirements

Interested?

Then please send us your current profile, availability, and hourly rate.

• Completed degree in Medicine, Pharmacy, Life Sciences, Biomedical Engineering, Engineering, Computer Science, or a comparable relevant field
• Demonstrable practical experience in the risk management of medical devices throughout the entire product lifecycle
• Sound knowledge of ISO 14971, ISO 13485, and relevant European medical device requirements
• Experience in the creation, review, and maintenance of complete and traceable Risk Management Files
• Experience in risk assessment of product changes, complaints, incidents, post-market information, and field experience
• Practical experience with methods such as hazard analysis, FMEA, fault tree analysis, and benefit-risk assessment
• Experience with medical device software or Software as a Medical Device
• Knowledge of software, usability, and cybersecurity-related safety risks
• Independent, structured, and evidence-based way of working
• Confident communication with technical and non-technical stakeholders in an international environment
• Fluent German and very good English skills, both written and spoken

Project details

• Start: 2026-11
• Duration: 9 Monate
• Remote: remote
• Location: Bochum, Deutschland, DE
• Languages: German