Regulatory Affairs Professional 3

This is a one year project.

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).
• SAP knowledge and hands-on experience
• Experience with medical device labeling review.
• Regulatory Affairs experience with in vitro diagnostics.
• Proficiency with Windows 10 and Microsoft Office 365.
• Ability to work with cross-functional team to collect data for UDI and updating in SAP

Duties Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:

• Gather regulatory and product information to support upload of this information to

SAP to support EU UDI.

• Identify and close gaps
• 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.