Risk Management Consultant (m/w/d)

Freelance Medical Device Risk Management Consultant

For an international medical device organization, we are looking for an experienced Risk Management Consultant to support an FDA QMSR readiness project.

Scope:

• Assess current Medical Device Risk Management processes and identify compliance gaps

• Improve methodologies across Hazard Analysis, Design/Process/Software FMEA

• Support FDA/QMSR inspection readiness

• Coach internal teams during pilot implementation

Requirements:

• Strong Medical Device Risk Management background

• Proven FDA/QMSR expertise

• Strong FMEA and compliance experience

• Experience in risk management transformation projects