Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)
Company: CorTech LLC
Posted on: May 3, 2021
Overall responsibility: Member of the IVDR RA international team
and responsible for preparing and providing documents for
registering assays and instruments worldwide.
Tasks include: Works in TEAMS and SharePoint to upload labeling and
documents. Dialogues with country RA to clarify requests and
provides the necessary documents including locating data within
reports and writing explanation letters. Maintains spreadsheets of
data; manipulates the data into summaries, pivot tables and graphs
Skills and education: College degree. Medtech background or
laboratory experience helpful. 3 yrs exp. w/medical devices or
IVDs. 1 yr exp in RA. Able to write clear, concise and sometimes
technical explanations to bridge gaps between existing documents
and country requirements. Good working knowledge of Office
applications, Outlook, Adobe Acrobat, TEAMS, SharePoint.
Work location: can be remote most of the time but must also be able
to get to Siemens office in Tarrytown, NY or Newark, DE.
Keywords: CorTech LLC, Newark , Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08), Other , Newark, Delaware
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