Risk Management Consultant

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