Corgenix Medical Corporation · 1 day ago
Scientific Program Manager, In Vitro Diagnostics Development and Validation
Broomfield, CO
Full-time
Onsite
Mid, Senior LevelCorgenix Medical Corporation is seeking a Scientific Program Manager to drive execution of complex IVD validation and regulatory programs. This role involves coordinating analytical and clinical testing for FDA and IVDR submissions while collaborating with cross-functional teams and external partners.
BiotechnologyHealth CareManufacturingMedical Device
Hiring Manager
Jessica Barkow, PhD
Responsibilities
Lead day-to-day program management for FDA and IVDR submission programs supporting autoimmune IVD products
Coordinate closely with the project management group at the sister company to align execution plans, dependencies, and timelines across organizations
Translate regulatory strategies and submission requirements into executable program plans encompassing analytical validation, clinical studies, and supporting documentation
Establish detailed milestones, deliverables, and interdependencies across internal teams, external partners, and sister-company functions
Track program progress, provide clear status reporting, issue early risk warnings, and drive mitigation and recovery plans as needed
Coordinate large-scale analytical and clinical testing activities required for FDA and IVDR filings across an extensive autoimmune IVD test menu
Ensure alignment of study designs, protocols, and execution with regulatory expectations and submission strategies
Lead technical and scientific discussions to resolve execution challenges and maintain data quality, consistency, and traceability across programs
Review and interpret analytical and clinical study data to support program decisions and regulatory readiness
Serve as the central coordination point for cross-functional teams, including R&D, clinical, regulatory, quality, manufacturing, and bioinformatics
Interface with external partners such as CROs, clinical sites, reference laboratories, and government agencies as required
Facilitate program meetings, drive decision-making, and ensure timely resolution of issues impacting submission timelines
Oversee preparation and alignment of program documentation, protocols, reports, and sponsor or regulatory communications
Qualification
Required
Master's degree or higher in a relevant scientific discipline, or equivalent experience
Demonstrated experience in scientific or technical program management, ideally within regulated diagnostics or medical device environments
Hands-on experience supporting analytical and/or clinical validation of IVD assays
Strong understanding of immunodiagnostic assay development (e.g., ELISA); familiarity with molecular diagnostics is a plus
Experience working under FDA and/or CE/IVDR regulatory frameworks
Working knowledge of design control processes, quality systems, and regulated product development lifecycles
Proven ability to manage complex, cross-company programs with multiple stakeholders and high execution demands
Proficient in basic statistical analysis
Highly organized, results-driven, and proactive, with the ability to adapt to evolving regulatory and program requirements
Preferred
PhD in a relevant life science discipline
Direct experience supporting FDA and/or IVDR submissions for autoimmune or immunology-focused IVD products
Experience coordinating large-scale analytical or clinical testing programs across multiple sites or organizations
Proficiency with formal project/program management tools (e.g., Microsoft Project)
Company
Corgenix Medical Corporation
Corgenix is part of the SEBIA Group.
Founded in 1990
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$1.25M2014-08-28Acquired
2010-07-16Series Unknown· $1.25M
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