Part of transformational strategy in Complaints Management for the PD Cluster
Complaints Handling, Vigilance Reporting, and Post Market Surveillance organization to ensure customer complaints are timely evaluated and to assure reportable events are submitted timely according to worldwide regulations
Working with the Business leads to ensure resources required are in place to achieve objectives
Keeping up to date on changes in regulations and standards, and ensure that the Vigilance Reporting team is trained on applicable regulations and standards and any other training required to execute complaint investigations
Serving as key partner and liaison between Medical Affairs, Clinical Affairs, Research & Development, and Manufacturing among others to ensure complaints are process in a timely manner and to ensure complaints are looped back to the product lifecycle
Reviews MDRs/MIR reports ensuring that the information is accurate and complete as per applicable requirements
Supporting inquiries from Regulators and Notify Bodies related to complaints management activities
Supports and participates in audits
Ensures that procedures and processes are compliant to applicable regulations
Monitors and drive process improvements based on performance against metric
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