Marcia Marchel

Make regulatory reporting determinations on applicable files for one or more Business Units. Prepares and submits Medical Device and/or Health Authority Reports within the required timelines. Responsible and accountable for the accuracy of submitted regulatory reports. Prioritizes work according to needs of department to support regulatory reporting and complaint investigation timeliness. Responds to regulatory requests within requested timeframes. Assists in the review of daily reports. Interacts with related agencies as requested. Familiarity with applicable regulations for Health Authority Reporting. Interacts positively with internal/external business partners and colleagues. Adheres and complies to work instructions, standard operating procedures, and regulations. Participates in tracking metrics for department. Achieves productivity targets. Participates in CAPA/NC/DR activities and can act as task owner as required. Assists with assignments of activities to meet deadlines. Maintains current training records. Proactive collaboration and resolution to cross-functional issues with stakeholders. All other duties as assigned by management.