Jun 24, 2025
Merck
Job Description This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices and medical device combination products. Primary activities include, but are not limited to: Serve as coordinator for management review of the company's device quality management system, including working with sites to collect, analyze and summarize data for management review meetings and presentations. Support device related internal, notified body and health authority inspections Provide support for quality system initiatives by generating, managing, and tracking gap assessments, quality plans, and CAPA Collaborate with global IT organizations to ensure medical device and medical device combination quality system aspects are integrated Stay abreast of evolving global regulatory...
Professional Diversity Network
Rahway, NJ, USA
Full-Time