Risk management consultant (m/f/d)

Industry: Medizintechnik
Skills: 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