Senior Data Standards Analyst

Experteer Overview In this role, you establish and govern enterprise data standards to support development, manufacturing, regulatory compliance and commercialization of medical devices. You work with cross-functional stakeholders to define data definitions, rules and governance that enable regulatory submissions, product traceability and trusted analytics. You will help ensure data is standardized, accurate and compliant across the product lifecycle. This opportunity suits a detail-focused professional who thrives in a regulated, data-driven environment and wants to impact quality and efficiency at scale. Compensation / Benefits * Develop, maintain and govern enterprise data standards, data definitions, naming conventions and reference data across MedTech functions * Define standardized data models and business rules for product, device, supplier, customer, manufacturing and regulatory master data * Collaborate with Regulatory Affairs and Quality to support compliance with FDA, MDR/IVDR, ISO 13485, UDI, GUDID and other global requirements * Coordinate with process owners to harmonize data definitions across ERP, PLM, QMS, CRM and other enterprise systems * Support data governance and master data management initiatives through policies and stewardship roles * Assess proposed system changes and new product introductions for alignment with data standards * Assist digital initiatives by specifying data needs and verifying adherence to standards * Participate in data governance councils and cross-functional teams to resolve data issues * Provide training to data stewards and business users on standards and governance best practices * Monitor industry trends and regulatory changes impacting data management Tasks * Bachelor’s degree in information systems, computer science, engineering, life sciences, business or related field * Minimum 5 years’ experience in data governance, master data management, business analysis or data management in a regulated industry * Experience in medical device, healthcare, pharmaceutical or life sciences sectors * Knowledge of data governance, metadata management and master data management * Understanding of medical device product lifecycle and regulated quality systems * Familiarity with global regulatory requirements (FDA, MDR/IVDR, ISO 13485, UDI) * Experience analyzing data with SQL, Excel, Power BI, Tableau or similar tools * Strong analytical, organizational and problem-solving skills * Excellent communication translating business requirements into data standards Key requirements * hybrid work model * potential for variable compensation and annual bonus targets * long-term incentives (subject to plan) * equal opportunity employer * career development and training opportunities

and ISO 13485, UDI, GUDID and other global requirements * Coordinate with process owners to harmonize data definitions across ERP, PLM, QMS, CRM and other enterprise systems * Support data governance and master data management initiatives through policies and stewardship roles * Assess proposed system changes and new product introductions for alignment with data standards * Assist digital initiatives by specifying data needs and verifying adherence to standards * Participate in data governance councils and cross-functional teams to resolve data issues * Provide training to data stewards and business users on standards and governance best practices * Monitor industry trends and regulatory changes impacting data management Tasks * Bachelor’s degree in information systems, computer science, engineering, life sciences, business or related field * Minimum 5 years’ experience in data governance, master data management, business analysis or data management in a regulated industry * Experience O _ medical device, healthcare, pharmaceutical or life sciences sectors * Knowledge of data governance, metadata management and master data management * Understanding of medical device product lifecycle and regulated quality systems * Familiarity with global regulatory requirements (FDA, MDR/IVDR, ISO 13485, UDI) * Experience analyzing data with SQL, Excel, Power BI, Tableau or similar tools * Strong analytical, organizational and problem-solving skills * Excellent communication translating business requirements into data standards Key requirements * hybrid work model * potential for variable compensation and annual bonus targets * long-term incentives (subject to plan) * equal opportunity employer * career development and training opportunities