Risk management consultant (m/f/d)
Skills: Risk Management, FMEA, FDA
- Manages risk management tasks (hazard identification, risk assessment and control).
- Performs risk analysis in compliance with ISO 14971.
- Coordinates risk management requirements together with QA/RA team, including compliance with ISO 14971 and internal SOPs.
- Handles risk management file and related documentation, including planning, execution, reports, reviews.
- Collaborates with Product Development team to identify appropriate risk mitigation strategies and implements
- Minimum experience: 5 years’ experience in risk management within medical device industry.
- Master’s degree in Biomedical Engineering or relevant field or equivalent combination of education and years of applicable experience.
- Experience with ISO 14971.
- Experience in structured traceability matrix (requirements-driven engineering, FMEA, formal verification, risk control measures, etc.).
- Normative and regulatory knowledge of ISO 14971, AAMI TIR 57, ISO 13485, MDR, 21 CFR 820.
- Fluency in English required, fluency in French (spoken) is a plus.
- Previous experience implementing the necessary processes and tools to develop risk management according to this standard.
- Experience performing risk management for complex medical devices (Class 2a or higher).
- Experience and/or sbackground in one or more of the following areas: