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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
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