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Regulatory Affairs 2

Company: APN Software Services, Inc
Location: Newark
Posted on: November 20, 2020

Job Description:

Regulatory Affairs Professional 2 Location Newark, DE 19702 Duration 12 Months Description Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017746) by performing the following bull Create and review technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017746EU). bull Gather regulatory documents and information to support creation of technical documentation. bull Identify and close gaps in technical documentation. bull Work collaboratively to complete tasks, both within regulatory affairs and with other departments. bull Create, review, and route for approval EU Declarations of Conformity. bull Provide periodic progress reports to supervisors. bull Attend in-person and teleconference meetings as assigned. bull Prepare finished IVDR technical documentation for submission to the Notified Body. bull Prepare quality records for electronic archival. Must Have bull Education Bachelor of ArtScience in a Science related field. bull Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics. bull Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel). bull Great time management and organizational skills. Preferred bull Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 9879EC) andor (b) the European In Vitro Diagnostic Regulation (IVDR 2017746). bull Experience with SAP. bull Experience with medical device labeling review. bull Regulatory Affairs experience with in vitro diagnostics. bull Proficiency with Windows 10 and Microsoft Office 365. Regards Daya Poojary APN Software Services INC 39899 Balentine Drive, Suite 385, Newark, CA 94560 Direct 510-857-5736 PhoneExtn. 124 Fax 510-623-5055

Keywords: APN Software Services, Inc, Newark , Regulatory Affairs 2, Other , Newark, Delaware

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