Clinical QA Specialist: Post-Market & Regulatory

Hologic, Inc. seeks a Clinical QA Specialist to lead investigation and reporting of adverse events and regulatory submissions, collaborating with cross-functional teams to ensure timely documentation and compliant outcomes. You'll apply knowledge of FDA QSR, ISO 13485, EU MDR, and ISO 14971 to drive risk assessments, CAPA activities, and post-market surveillance across the product portfolio. This role emphasizes proactive problem solving, strong communication with regulatory agencies, and a