Regulatory Submission Specialist (EU IVDR)
Job Summary
Seeking a full-time remote Regulatory Submission Specialist (EU IVDR) who will manage the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices, ensuring compliance with international regulations throughout the product lifecycle.
Key responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, instructions for use, and labelling for regulatory alignment
- Coordinate evidence collection from various internal and external stakeholders to support regulatory submissions
Required qualifications
- Bachelor's degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or a related discipline
- 2+ years of experience in regulatory affairs for medical devices or in vitro diagnostic devices
- Experience with CE-marking documentation under the EU IVDR, including technical documentation and performance evaluation requirements
- Working knowledge of IVD quality and regulatory frameworks, such as ISO 13485 and ISO 14971
- Experience in reviewing or preparing analytical-performance and clinical-performance documentation for IVDs
Complete Job Description
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