Job Summary
We are seeking an experienced Business Systems Analyst (BSA) that supports regulatory compliance, patient safety, and continuous product improvement through accurate and timely documentation, assessment, investigation, reporting, and resolution of customer complaints. This role will support the Product Surveillance Manager in various post-market product surveillance activities, Quality , Logistics, Receiving team for the return process, Supplier Quality team for the Supplier related process, Quality compliance group for Nonconformance, Standalone and Audit module . The ideal candidate will partner with Quality Compliance, Manufacturing, and IT teams to gather business requirements, implement system enhancements, and ensure compliance with FDA regulations, global health regulatory requirements, and internal quality standards while participating in system validation activities and ensuring all enhancements follow established Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. Provide risk-based guidance and regulatory input to projects and issues while ensuring cross-functional alignment and resolution.
Key Responsibilities
- Partner with business stakeholders to elicit, analyze, document, and validate business and system requirements for QMS enhancements and projects.
- Support and administer the Complaint, Return Material Authorization (RMA), and Supplier Quality Management (SQM), Nonconformance, Standalone CAPA modules within the QMS.
- SQL Expertise: Experience with Microsoft SQL Server Management Studio (SSMS). Advanced proficiency in T-SQL, PL/SQL, and SQL Server Management Studio (SSMS).
- AssurX Experience: Hands-on experience configuring Eventhooks, Datalinks and managing the AssurX Quality and Compliance software including Complaints, RMA, Supplier Management and Audit modules.
- Database Architecture: Solid understanding of database design, normalization, indexing, and query optimization.
- Experience with data validation, migration, and reconciliation.
- Data Integrity: Ensure data accuracy, consistency, and HIPAA/FDA compliance (such as 21 CFR Part 11) across all database environments.
- System Integration: Develop and maintain ETL processes and APIs to integrate the AssurX and Trackwise platform with enterprise systems such as ERP, SAP, CRM, or Active Directory.
- Regulatory Knowledge: Familiarity with quality standards and regulatory compliance (e.g., ISO, FDA, GxP).
- Communication: Strong analytical and cross-functional communication skills to translate business requirements into technical database solutions.
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