Senior Regulatory Affairs Professional

Versiti fuses donors, scientific curiosity, and precision medicine to advance transfusion medicine, transplantation, stem cells, cellular therapies, oncology, genomics, and diagnostic lab services. This senior role provides advanced support to the Quality department in regulatory affairs, acting as a key team member to achieve departmental goals. It bolsters the overall quality program while serving as a liaison across service lines.

The position supports execution of the Quality Plan, ensuring compliance with regulations and integrating continuous improvement practices into quality systems and activities. Daily tasks include reviewing quality metrics from charts and tables to identify action areas and collaborating with service lines on corrective measures. It also involves assessing regulatory changes for process impacts and communicating updates to management.

As a senior specialist, the role partners with service lines to deliver regulatory input on projects and routine tasks, facilitating optimal communication during internal and external assessments. It acts as a resource for regulatory and quality matters, reviewing events in the management system for investigation adequacy and corrective actions. This collaboration enhances patient outcomes, service quality, and cost efficiency for healthcare partners.

Team members contribute to developing, compiling, and submitting regulatory submissions while reviewing and approving SOPs, validation plans, and corrective actions. The environment fosters passion for improving patient lives and supporting healthcare partners. Opportunities arise in leading quality initiatives and providing internal/external regulatory guidance.