Senior Data Standards Analyst

Additional Location(s): US-MN-Arden Hills

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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

The Data Standards Analyst is responsible for establishing, maintaining and governing enterprise data standards that support the development, manufacturing, regulatory compliance and commercialization of medical devices. This role ensures product, regulatory, supplier, customer and operational data are standardized, accurate and compliant across enterprise systems throughout the product lifecycle.

Working closely with cross-functional business stakeholders, the Data Standards Analyst develops data definitions, business rules and governance processes that enable regulatory submissions, product traceability, operational excellence and trusted analytics.

The ideal candidate has experience with data governance, master data management, health care or medical device standards, and cross-functional business processes in a regulated environment.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Develop, maintain and govern enterprise data standards, business definitions, naming conventions and reference data across Med Tech business functions.
• Define standardized data models and business rules for product, device, supplier, customer, manufacturing and regulatory master data.
• Partner with Regulatory Affairs and Quality teams to support compliance with FDA, MDR/IVDR, ISO 13485, UDI, GUDID, EUDAMED and other applicable global regulatory requirements.
• Collaborate with business process owners to establish common data definitions and improve consistency across ERP, PLM, QMS, CRM and other enterprise applications.
• Support enterprise data governance and master data management initiatives by documenting standards, policies and stewardship responsibilities.
• Evaluate proposed system changes and new product introductions to ensure alignment with established data standards.
• Support the implementation of new digital initiatives by defining data requirements and validating adherence to enterprise standards.
• Participate in data governance councils and cross-functional working teams to prioritize and resolve data-related issues.
• Provide guidance and training to data stewards and business users on data standards, governance processes and best practices.
• Monitor industry trends and emerging regulatory requirements that affect enterprise data management.

Required qualifications:

• Bachelor's degree in information systems, computer science, engineering, life sciences, business or a related field.
• Minimum of 5 years' experience in data governance, master data management, business analysis or data management within a regulated industry.
• Experience working in the medical device, health care, pharmaceutical or life sciences industry.
• Knowledge of data governance principles, metadata management and master data management.
• Understanding of medical device product lifecycle processes and regulated quality systems.
• Familiarity with global regulatory requirements, including FDA, MDR/IVDR, ISO 13485 and UDI.
• Experience analyzing data using SQL, Excel, Power BI, Tableau or similar reporting tools.
• Strong analytical, organizational and problem-solving skills.
• Excellent…