Senior Product Complaint Operations Specialist

Role: Senior Product Complaint Operations Specialist, ensuring end-to-end handling of product complaints for devices, drugs, biologics, and combination products across the product lifecycle. Responsibilities: manage complaint workflows, monitor compliance with global regulations (EU MDR, 21 CFR, ISO standards), develop and deliver training, support investigations, and collaborate with internal and external stakeholders including vendors and regulatory bodies. Maintain quality systems, support audits, and drive process improvements to enhance complaint management efficiency. Requirements: Bachelor’s in a relevant field; 5+ years in pharmacovigilance or product complaint management for devices or biologics; experience with safety databases like Argus; understanding of drug/device development and regulatory frameworks; strong communication, project management, and analytical skills. Preferred: Master’s degree; post-marketing or product development experience. HighValue: focus on device, biologic, and combination products; global regulatory compliance; quality and patient safety impact; hybrid work setup at Durham, NC with some travel; involvement in inspections and CAPA processes.