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Recall Coordinator 1

Hologic, Inc. · Newark, Delaware, US

Are you a quality-focused professional with a passion for ensuring product safety and compliance in the medical device industry? We are seeking a dynamic Rec...

Job description

Are you a quality-focused professional with a passion for ensuring product safety and compliance in the medical device industry? We are seeking a dynamic Recall Coordinator to oversee the preparation and execution of Field Actions for our Breast and Skeletal Health divisions. Based in Newark, DE, this pivotal role requires onsite presence and offers the opportunity to make a significant impact on global recall strategies and regulatory communications. Qualifications: Preferred Minimum Technical Degree: BA/BS Degree Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System. Demonstrates independent decision-making and prioritization, including resolving conflicts and taking leadership roles on critical tasks. Field Action Management: - Support the management and coordination of the preparation and execution of field actions globally. - Participate in cross-functional meetings to develop plans and deliverables for various activities supporting Field Actions. Global Recall Strategies: - Collaborate with divisional stakeholders to develop comprehensive global recall strategies and regulatory communications. - Coordinate with Hologic...