Sr. Director, RA/QA Strategy & Business Integration

Role: Senior Director, RA/QA Strategy & Business Integration, serving as the primary interface between Regulatory Affairs/Quality Assurance and internal cross-functional teams (Product, R&D, Operations) as well as external partners. Objectives include shaping regulatory and product strategies, integrating RA/QA early into development, and positioning RA/QA as a strategic driver of innovation and competitive advantage. Responsibilities encompass leading cross-functional governance, guiding development pathways for biotech/diagnostics products, and representing FMI externally to influence industry standards. Qualifications: Bachelor’s in Life Sciences, Engineering, or related field; 12+ years in QA/RA within biotech, diagnostics, or medical devices; extensive experience in regulatory strategy supporting product development in regulated environments (FDA, CLIA, IVDR); 5+ years of leadership in matrixed organizations, with influencing and stakeholder engagement skills. Preferred: Advanced degrees (PhD, MS, MBA), expertise in diagnostics, IVD, or precision medicine, and experience in global regulatory landscapes. High-Value: Focus on diagnostics/IVD, regulated product lifecycle support, external engagement, and strategic leadership. Work setup: Remote, with expectations for external representation and stakeholder collaboration.