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Regulatory Affairs Professional 2 (QM - QM - REGAF - PR08)

Company: CorTech LLC
Location: Newark
Posted on: May 3, 2021

Job Description:

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 for reporting.
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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