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Regulatory Affairs Professional 2

Company: Cortech
Location: Newark
Posted on: January 5, 2022

Job Description:

Overall responsibility: Member of the IVDR RA international team and responsible for preparing and providing documents for registering assays and instruments worldwide.1. Review design changes and obtain supporting documentation (reports) from SAP/Documentum. Transcribes information on a design change into a letter of explanation.2. Dialogues with country RA to answer questions from country regulatory authorities on IVDR labeling changes. This includes dialoguing with other departments for additional information, locating data within reports and writing explanation letters.3. Submits documents for legalization/apostille and manages the process.4. Works in TEAMS and SharePoint to upload labeling and documents.5. 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. Very proficient in Office applications, Outlook, Adobe Acrobat, TEAMS, SharePoint.

Keywords: Cortech, Newark , Regulatory Affairs Professional 2, Other , Newark, Delaware

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