Regulatory Submission Specialist
Job Summary
Seeking a full-time remote Regulatory Submission Specialist, the candidate will manage the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices, ensuring compliance with international IVD regulatory requirements.
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 internal teams and external consultants 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 EU IVDR, including technical documentation and performance evaluation
- Working knowledge of IVD quality and regulatory frameworks, including ISO standards
- Experience preparing analytical-performance and clinical-performance documentation for IVDs
Complete Job Description
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