Franziska Walter

- Regulatory product ownership for devices (class I-III) - Prepare dossiers for variations and renewals - MDR preparation - Assess Change Controls for impact on regulatory compliance and registrations - Supervision of activities for regulatory submissions and maintenance of medical devices in EU, EMEA region and ROW (rest of world) - Responding to or coordination of queries of Health authorities - Assure that regulatory submission needs are met in a timely and efficient manner

- Regulatory product ownership for devices (class I-III) - Prepare dossiers for variations and renewals - Assess Change Controls for impact on regulatory compliance and registrations - Supervision of activities for regulatory submissions and maintenance of medical devices in EU and EMEA region (Eastern Europe, Middle East, Africa) - Responding to or coordination of queries of Health authorities - Assure that regulatory submission needs are met in a timely and efficient manner

- Maintenance of regulatory files in a format consistent with legal requirements - Preparation of submission dossiers for new device registrations and renewals in EMEA (Eastern Europe, Middle East, Africa) region - Maintenance of EC certificates and electronic databases related to CE marked products