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Regulatory Affairs Professional 2

at APN Software Services 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.

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. 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 office in Tarrytown, NY or Newark, DE or Flanders, NJ. 

 

As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.

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Job Posting: 839931

Posted On: Sep 02, 2021

Updated On: Oct 12, 2021