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Regulatory Affairs Professional

at VIVA USA Inc in Newark, Delaware, United States

Job Description

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. Note : 8:30a – 5p Work location: can be remote most of the time but must also be able to get to the client office in Tarrytown, NY or Newark, DE. VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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Job Posting: JC191436152

Posted On: Sep 03, 2021

Updated On: Oct 06, 2021