Overview

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 2017/746) by performing the following:
• Create and review technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
• Gather regulatory documents and information to support creation of technical documentation.
• Identify and close gaps in technical documentation.
• Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
• Create, review, and route for approval EU Declarations of Conformity.
• Provide periodic progress reports to supervisors.
• Attend in-person and teleconference meetings as assigned.
• Prepare finished IVDR technical documentation for submission to the Notified Body.
• Prepare quality records for electronic archival.

Must Have
• Education: Bachelor of Art/Science in a Science related field.
• Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
• Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
• Great time management and organizational skills.

Preferred
• Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
• Experience with SAP.
• Experience with medical device labeling review.
• Regulatory Affairs experience with in vitro diagnostics.
• Proficiency with Windows 10 and Microsoft Office 365.

Regards

Daya Poojary
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560

Direct:
PhoneExtn. 124
Fax:

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