MedTech Data Standards Analyst – Governance & Compliance

Boston Scientific; Marlborough (MA); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific seeks a Data Standards Analyst to establish, maintain and govern enterprise data standards across the product lifecycle in a regulated environment. You will define data models, master data definitions and governance processes to enable regulatory submissions and trusted analytics.

The role collaborates with Regulatory Affairs and Quality and other cross-functional teams to ensure compliance with FDA, MDR/IVDR, ISO 13485, UDI and related standards, while supporting data

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 communication skills with the ability to translate business requirements into data standards.

Responsibilities

• Develop, maintain and govern enterprise data standards, business definitions, naming conventions and reference data across MedTech 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.

Skills

Data governance

Master data management

SQL

Excel

Power BI

Tableau

Analytical skills

Education

Bachelor's degree in information systems, computer science, engineering, life sciences, business or related field

Tools

SAP

Oracle

Windchill

Teamcenter

Arena

Collibra

Informatica

Microsoft Purview

Alation

Job description

Boston Scientific seeks a Data Standards Analyst to establish, maintain and govern enterprise data standards across the product lifecycle in a regulated environment. You will define data models, master data definitions and governance processes to enable regulatory submissions and trusted analytics.

The role collaborates with Regulatory Affairs and Quality and other cross-functional teams to ensure compliance with FDA, MDR/IVDR, ISO 13485, UDI and related standards, while supporting data