Tarrytown, United States
3 months ago
This is a one year project.
- 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.
- 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.