Associate Director, MDS Regulatory Affairs Systems & Operations
Core
Lead regulatory affairs systems, operational processes, and data governance for medical device compliance and global regulatory operations.
Role type
Senior IC regulatory affairs systems and operations leader
Builds
Regulatory data integrity, audit readiness, and global compliance frameworks for medical devices
Domain
Medical device regulatory affairs and quality management systems
Required skills
Regulatory affairs leadership, QMS governance, audit process management, system governance, data quality oversight, change control, UDI management, FDA registration oversight, global regulatory intelligence, cross-functional stakeholder management
Preferred skills
Master's degree, RAC or ASQ certification, experience with RIM/RIMSYS, PIM, EUDAMED, GUDID, PEGA workflows, eIPRRA, SharePoint, Power BI, MDSAP support, Lean/Kaizen methodologies, distributed team management
Technologies
RIM/RIMSYS, PIM, EUDAMED, GUDID, PEGA, eIPRRA, SharePoint, Power BI
Responsibilities
Establish governance for regulatory systems and data quality, own audit process readiness, manage regulatory intelligence and UDI databases, oversee FDA registration and change control frameworks, lead global eUMDR transition, enable training and capability development for regulatory teams
Seniority
Senior, hands-on IC with leadership responsibilities