Senior Data Standards Analyst
Core
Establishing, maintaining, and governing enterprise data standards to support the development, manufacturing, regulatory compliance, and commercialization of medical devices.
Role type
Senior Data Standards Analyst
Builds
Standardized data models, business rules, and governance processes for product, regulatory, supplier, and operational data.
Domain
Medical Devices / Healthcare / Regulatory Compliance
Required skills
Data governance, Master Data Management (MDM), Regulatory compliance (FDA, MDR/IVDR, ISO 13485, UDI), Cross-functional collaboration, Data modeling, ERP/PLM/QMS/CRM systems knowledge, Documentation and policy creation, Data stewardship.
Preferred skills
Experience in MedTech industry, Knowledge of global regulatory requirements (EUDAMED, GUDID), Data quality management.
Technologies
ERP, PLM, QMS, CRM, GUDID, EUDAMED, UDI systems.
Responsibilities
Develop and govern enterprise data standards and naming conventions; Define standardized data models for master data; Partner with Regulatory and Quality teams for compliance; Collaborate on common data definitions across enterprise applications; Support data governance initiatives; Evaluate system changes for standard alignment; Support digital initiatives with data requirements; Participate in data governance councils; Provide training to data stewards.
Seniority
Senior, hands-on IC
