Associate Director, Global PV Product Complaint Management & Oversight

Role: Associate Director, Global PV Product Complaint Management & Oversight, leading the global governance of product complaints across devices, drugs, biologics, and combination products throughout all lifecycle stages. Responsibilities: oversee complaint handling processes, develop and implement global procedures, ensure compliance with international regulations (EU MDR, IMDRF, 21 CFR, ISO standards), lead inspection readiness, and foster continuous improvement in safety governance. Manage cross-functional teams and vendor relationships, provide training, and lead audits and CAPAs. Qualifications: Bachelor's or higher degree in a relevant field; 7+ years' pharmacovigilance or product complaint experience supporting devices, biologics, or combination products; experience with vendor oversight, post-marketing drug exposure, and safety databases (preferably Argus). Core skills include deep knowledge of GMP/GDP, ISO standards, global regulatory requirements, and end-to-end case processing. Preferred: Master's degree or PharmD. High-Value: global pharmacovigilance, product complaint oversight, regulatory compliance, medical device/software safety, vendor management, inspection readiness. Location: Durham, NC with hybrid work; travel as needed.