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Location
Newark, United States
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Sector:
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Job type:
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Contact:
Sonu Chouhan
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Job ref:
21776
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Published:
about 1 year ago
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Expiry date:
2020-10-24
- 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.