Regulatory Submission Specialist
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist will prepare, review, and submit regulatory documentation while ensuring alignment with international IVD regulatory requirements.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, labelling, and specifications 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 the EU IVDR (Regulation (EU) 2017/746)
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Familiarity with relevant IVD standards and guidance, including CLSI EP guidelines
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