Senior Specialist Quality Assurance
Core
Manages day-to-day compliance with domestic and international regulations, complaint handling, and Medical Device Report (MDR) submissions for medical diagnostic products.
Role type
Senior Specialist Quality Assurance (Medical Device Compliance)
Builds
Regulatory compliance processes and Medical Device Reports for Abbott Point of Care diagnostic products.
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Regulatory compliance management, complaint handling, report filing, data analysis, cross-functional collaboration, process monitoring, metrics verification, reportable malfunction list management
Preferred skills
FDA Quality System Regulations (21 CFR Part 820), GMP, ISO 13485:2016, enterprise business unit models
Technologies
Statistical/data analysis tools, report writing software
Responsibilities
Schedule and review medical event files within established timeframes, assess complaints for reportability and file necessary reports, coordinate with Medical Affairs and Technical Support teams, manage the Reportable Confirmed Malfunction List (RCML) process, verify vigilance reports and compiled data metrics, collaborate with international country offices.
Seniority
Senior, hands-on IC