Tarrytown, United States
over 1 year ago
Supports International Regulatory Affairs Team in Tarrytown, NY with ADVIA Centaur and Atellica products registrations worldwide. Prepares and provides documents to comply with regulatory requirements with special focus on China regulations. Compiles product registration dossiers in a timely manner. Works with Intl RA team and Siemens Regional Units (RU) to ensure that documents are provided and licenses are obtained according to agreed timelines. Performs and/or trains on the established process to assure data are collected in timely and cost effective manner and is consistent with international regulatory requirements and quality standards. Maintains the tracking of submission documents. Completes daily progress reports on regulatory submissions to support license approvals. Must be detailed oriented, focused, able to multi-task, and work under tight deadlines.
Must have at least 3 years experience