o Identify and assess recorded complaints, record the outcome of analysis. Lead the assessment with experts.
o Ensure timely follow up of recorded issues with potential risks for patients, users & public safety (PUPS). Lead PUPS risk assessment with experts and record outcomes of safety risk assessments. Identify PUPS issues to be escalated to management.
o Determine and document the need to report to competent authorities based on regulations and risk assessment. Prepare and submit the report to competent authorities in a timely manner. Follow up implementation of corrective and preventive actions until report final closure.
o Handle interaction with the external & internal stakeholders (such as Notified Body, Competent Authorities, market authorization holders …) for vigilance reporting of IBA products.
o Prepare external/internal communication for safety issues with support of other departments.
o Collect proactively and analyze alerts on systems similar to IBA medical devices through market screening, define actions and document corresponding records.
o Identify necessary inputs for Post Market Surveillance. Analyze data received related to quality, safety or performances of IBA medical devices and similar systems after they have been placed on the market and record analysis output. Interact with other stakeholders and ensure facilitation & documentation of all PMS activities.
o Create, maintain & improve post market processes & documentation. Ensure compliance to regulations through Regulatory Watch activities and operational efficiency.
o Analyse KPI & trend reporting of post market activities on IBA products, escalate when appropriate, record results of analysis.
o Develop and provide training to internal customers about complaints, medical device reporting and post market vigilance.
o Support audits for post-market activities.
