Business Analyst – FDA Compliance / OpenText Documentum

Job Title: Business Analyst – FDA Compliance / OpenText Documentum Location: New York / New Jersey, USA Type: Contract Summary:Seeking a Business Analyst with 7–10 years’ experience and strong expertise in FDA regulations/compliance and OpenText Documentum (ECM). The role focuses on translating regulatory requirements into clear documentation, improving processes, and supporting compliant project delivery.Key Responsibilities:Gather, analyze, and document business requirements aligned to FDA regulations Create BRDs and functional specifications Work with cross-functional teams and SMEs to ensure compliance Analyze current processes and recommend improvements Act as liaison between business and technical teams Support FDA-compliant workflows, documentation, and reporting Mandatory Skills:Strong knowledge of FDA regulatory framework Hands-on experience with OpenText Documentum / ECM Excellent documentation, analysis, and communication skills Nice to Have:CPG / Food Safety / FSQA domain exposure Experience with workflows, D2 SmartView, integrations Agile/Waterfall understanding Qualification:Bachelor’s degree with 7–10 years BA experience