Newark, United States
about 1 year ago
- Maintain technical files for in vitro diagnostic products in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
- Prepare and review technical file submissions for reagents, calibrators, controls and verifiers against relevant standards.
- Provide regulatory review of the claims and technical files to maintain EU CE marking.
- Investigate and close GAPs in documentation for technical files.
- Support e-filing by reviewing and logging files to be uploaded into Documentum.
- Upload and QC files in Documentum.
- Experience with SAP.
- Education requirements: Bachelors of Art/Science in a Science related field
- Regulatory Affairs Experience Preferred.