Regulatory Submission Specialist
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Job Summary
Managing the lifecycle of regulatory submissions, the full-time Regulatory Submission Publishing Specialist will prepare, publish, validate, and electronically submit regulatory dossiers for diagnostic products in a remote capacity.
Key responsibilities
- Prepare and publish regulatory submissions using specialized platforms and electronic gateways
- Review validation reports, resolve publishing errors, and ensure compliance with regulatory standards
- Implement process improvements and maintain regulatory document repositories for audit readiness
Required qualifications
- Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field
- 5+ years of regulatory submission publishing experience in diagnostics or related life sciences
- Experience with FDA, EMA, and ICH regulatory requirements
- Knowledge of diagnostic and life sciences regulatory submissions, including 510(k), PMA, BLA, IND, IDE, and IVDR
- Experience in submission lifecycle management and regulatory document management
Complete Job Description
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