Regulatory Affairs Specialist
Tarrytown, NY - 10591
12 months contract to start with (extendable contract)
Supports International Regulatory Affairs Team in Tarrytown, NY with ADVIA Centaur and Atellica product registrations in Asia Pacific countries.
Prepares and provides documents to comply with regulatory requirements with special focus on India new regulations.
Completes the development of Device Master File (DMF) documents 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 regulatory requirements and quality standards.
Completes the tracking of submission documents.
Completes daily progress reports on regulatory submissions to support license approvals.
Must be detailed oriented, focused, and able to work under pressure with tight deadlines.