Regulatory Submission Specialist

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