Risk management consultant (m/f/d)
This job offer is no longer available.
Lausanne, Schweiz |
Temporary Employment
Job title: Risk management consultant (m/f/d)
Industry: MedizintechnikSkills: Risk Management, FMEA, FDA
Start of project: 01.11.2023
Duration of the project : 3 months
Project volume: 504 Hour(s)
Location: Lausanne, Switzerland
Tasks:
- 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
Qualifications:
- 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:
- Experience in risk management activities for medical device software and link between ISO 14971 and IEC 62304
- Experience with FDA software validation, Cybersecurity, Data Protection and Artificial Intelligence guidance
- Medical electrical equipment – IEC 60601 series
Reference number: 13722
Industry: Medizintechnik
Project start: 01.11.2023
Duration: 3 months
Employment type: Temporary Employment
Contact
Oleksandra Moroz