Carrie Brookner

Background

About Carrie Brookner

Biomedical Engineering Ph.D. with diverse experience in product development within the medical device industry and in driving high-level strategic initiatives. Detail oriented and organized with strong written and verbal communication skills. Strong knowledge of FDA regulations, guidance documents and submission pathways. Qualifications Summary• Experienced submission specialist with successful 510(k) and EU MDR submissions • Very analytical, detail-oriented, organized, and focused on delivering results with a proven record of leading cross-sector teams spearheading strategic/corporate initiatives, controlling budgets, optimizing resource planning, and completing projects. • Demonstrated excellence in preclinical studies, pilot clinical studies, cancer screening technologies, competitive technology assessment, and data analysis.• Completed graduate certificate program in Medical Device Regulatory Affairs and coursework in clinical research. Gained extensive knowledge of US FDA regulations, global regulations, and international standards. • Prepared to manage the global regulatory aspects of new product development and lifecycle change control support, including developing regulatory strategies to maintain standards and ensure the safety and quality of products.