Graduate Certificate: Quality Assurance and Regulatory Affairs

Program Details

The Quality Assurance and Regulatory Affairs (QA/RA) Certificate Program is an interdisciplinary program designed to upskill or reskill aspiring or working professionals interested in expanding their knowledge of how to bring a medical product to market including regulations, quality management systems, risk management, compliance, auditing and inspection metrics, design controls, and best practices. QA/RA employees are critical to designing, running, and reporting the testing required to show medical products comply with quality standards and regulations at each stage of the product lifecycle. QA/RA positions lead hiring demands in biotech, however, nearly 32% of companies surveyed ranked QA/RA openings as the most difficult roles to fill, providing a clear opportunity for upskilling and reskilling.