Senior Data Standards Lead – Hybrid MedTech

Boston Scientific; Arden Hills (MN); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Data Standards Analyst to establish, maintain and govern enterprise data standards across the product lifecycle in a regulated medical devices environment. You will collaborate with Regulatory Affairs, Quality, IT and business stakeholders to define data definitions, master data management, governance processes and regulatory submissions.

The role requires experience with data governance tools, SQL and analytics platforms; a strong communicator able to translate

Qualifications

• Bachelor's degree in information systems, computer science, engineering, life sciences, business or a related field.
• Minimum 5 years' experience in data governance, master data management, business analysis or data management within a regulated industry.
• Experience in medical device, health care, pharmaceutical or life sciences.
• 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 tools.
• Strong analytical, organizational and problem-solving skills.
• Excellent communication skills translating business requirements into data standards.

Responsibilities

• Develop, maintain and govern enterprise data standards across 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 regulatory compliance.
• Collaborate with process owners to establish data definitions and improve ERP/PLM/QMS/CRM data consistency.
• Support data governance and master data management initiatives with documented standards and policies.
• Evaluate proposed system changes to ensure alignment with data standards.
• Support new digital initiatives by defining data requirements and validating standards adherence.
• Participate in data governance councils and cross-functional teams to resolve data issues.
• Provide training to data stewards and users on data standards and governance.
• Monitor industry trends and regulatory requirements affecting data management.

Skills

SQL

Excel

Power BI

Tableau

Data governance

Regulatory compliance

Analytical thinking

Communication

Education

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

Tools

SAP

Oracle

Windchill

Teamcenter

Arena

Collibra

Informatica

Microsoft Purview

Alation

Job description

Boston Scientific is seeking a Data Standards Analyst to establish, maintain and govern enterprise data standards across the product lifecycle in a regulated medical devices environment. You will collaborate with Regulatory Affairs, Quality, IT and business stakeholders to define data definitions, master data management, governance processes and regulatory submissions.

The role requires experience with data governance tools, SQL and analytics platforms; a strong communicator able to translate