Senior Director, Quality & Regulatory Notified Body Audits

Role: Senior Director of Quality & Regulatory (Q&R) Notified Body Audits, overseeing global certification strategies, audit governance, and compliance activities within GE HealthCare. Responsibilities: manage relationships with Notified Bodies, lead certification management including transfers and scope expansions, oversee audit processes (technical reviews, surveillance, recertification), and develop global processes for audit readiness and improvement. Lead QMS integration assessments post-M&A activities, providing strategic insights and metrics to executive leadership. Requirements: Master’s degree with 10+ years or bachelor’s with 15+ years in medical device industry; deep knowledge of QMS and regulations (FDA CFR 21 820, EU MDR, ISO 13485, MDSAP); 5+ years supporting Notified Body interactions; strong experience in metrics development, data analysis, and cross-functional communication. Preferred: familiarity with EU MDR, MDSAP, ISO 9001, UKCA, and experience managing certification portfolios; ability to influence global strategy, manage complex stakeholder relationships, and travel up to 20%. HighValue: focus on compliance and certification within medical devices, supporting global regulatory frameworks, quality management systems, and risk mitigation across manufacturing and development sites.