Risk management consultant (m/f/d)

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Lausanne, Schweiz |

Temporary Employment

Job title: 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

Referenznummer:

Branche:

Beginn des Projekts:

Dauer:

Anstellungsart:

Kontakt

Oleksandra Moroz

13722

Medizintechnik

01.11.2023

3 months

Temporary Employment