Global Post Market Surveillance Clinical Expert

Job Summary

A company in the healthcare industry is looking for a Global Post Market Surveillance Clinical Expert.

Position Responsibilities:

• Conduct preliminary clinical assessments for issues alleging significant injury or death for product and provide input for Issue Impact Assessments (IIA)
• Participate in Executive Correction and Removals Governance Board meetings and provide clinical insights to support consistent decision making
• Implement and improve the standard way of operating for clinical input to ensure that respective processes are timely, effective and efficient

Required Qualifications:

• Must be a licensed or certified healthcare professional with patient care experience
• Bachelor's degree or higher in science with a preference towards healthcare or medical profession (e.g. nurse, nurse practitioner, physician assistant)
• Experience with FDA and/or other regulatory audits/inspections is required
• Knowledge of regulations relative to corrections and removals, complaint handling and reporting, and risk management such as: ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 820)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR
• Post Market experience preferred