About this role
Director, Quality Assurance and Regulatory Affairs at Meridian Bioscience, Inc.. Location: North Billerica, Massachusetts, United States. Role: ensuring compliance, managing quality, leading team Requirements: Bachelor's in Biological Science/Engineering/Health Sciences required (Master's preferred). 10+ years leading in medical devices, 5+ years IVD experience; knowledge of 21 CFR Part 820, ISO 13485, ISO 14971; experience with regulatory submissions, recalls/MDRs, CAPA, and electronic document systems. Category: Quality Assurance Seniority: Senior Level Tools: ERP Certifications: rac, asq Commitment: Full Time Workplace: Onsite Languages: English