Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs leads the development and execution of ex-US regulatory strategy for NGS-based in vitro diagnostic products, with a primary focus on EU IVDR and Health Canada markets. This role manages regulatory relationships with biopharma partners for companion diagnostic co-development programs and ensures alignment with US FDA frameworks. The position serves as a strategic partner to leadership, shaping international clinical and regulatory pathways while mentoring team members and driving cross-functional collaboration.