Regulatory Submission Specialist (EU IVDR)
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist (EU IVDR) will manage the preparation, review, and submission of regulatory documentation while ensuring alignment with international IVD regulatory requirements.
Key responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation
- Review product claims, instructions for use, and labelling for regulatory alignment
- Coordinate evidence collection from internal teams and external consultants to confirm compliance throughout the product lifecycle
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, including ISO 13485 and ISO 14971
- Experience preparing analytical-performance and clinical-performance documentation for IVDs
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