Lead/Senior Head OF Quality

Abbott in Alameda, CA seeks a senior Quality & Regulatory professional to lead complex regulatory initiatives ensuring patient safety and compliance. You will prepare MDRs, MedWatch, and Vigilance reports while coordinating with complaint handling, medical affairs, and product quality teams. Role requires 5+ years in regulated environments, knowledge of 21 CFR Part 11 and ISO 13485, and the ability to drive CAPA and quality system improvements. Travel up to 10% is expected.