Newark, United States
about 1 year ago
- Analyzes the requirements and prepares product related regulatory submissions for IVDR.
- Provide regulatory review of the claims and technical files to maintain EU CE marking
in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
- Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
- Investigate and close GAPs in documentation for technical files.
- Troubleshoots and analyzes categorization, intended purpose and other IVDR topics
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for related audits/inspections.
- 5-8 years Deep professional know-how and experience in Regulatory affairs (preferably IVD products). Solid professional judgment and problem solving competence. Improves existing processes and approaches.