JOB DESCRIPTION:The OpportunityThis is an onsite role located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remote role/opportunity.IT
Business Relationship Manager for Complaint Process Automation plays a critical role in driving digital transformation and operational excellence within Abbott's Post-Market Surveillance (PMS) and complaint handling functions. The Lead Business Analyst supports the delivery of
compliance, quality, and process automation initiatives by serving as the liaison between business stakeholders and technology teams. This role is responsible for gathering requirements, documenting business processes, supporting solution design, coordinating testing activities, and assisting with implementation and business readiness efforts. The individual works closely with Quality, Regulatory, Operations, and IT teams to ensure business needs are understood and translated into effective technology solutions that improve compliance, efficiency, and operational performance.
Core Job ResponsibilitiesBusiness Analysis- Gather, analyze, and document business requirements, functional specifications, business rules, and process workflows.
- Facilitate requirements, workshops and stakeholder discussions.
- Develop business cases, process maps, use cases, and acceptance criteria.
- Serve as the primary liaison between business stakeholders and technical teams to ensure successful delivery.
- Ensure requirements are traceable, prioritized, and aligned with strategic business objectives.
Business and IT Alignment:• Act as a liaison between business units and IT teams to ensure process requirements are accurately translated into technical solutions.
• Support solution architects and delivery teams by providing process insights and ensuring alignment with business objectives.
- Lead cross-functional initiatives from concept through deployment and operational stabilization.
- Develop business cases, requirements, implementation of roadmaps, and success metrics.
- Coordinate with IT organizations, vendors, and business teams to ensure timely and compliant solution delivery.
- Support user acceptance testing, validation activities, change management, and training efforts.
- Manage project risks, dependencies, and stakeholder communication throughout project lifecycles.
- Drive execution of strategic initiatives aligned with business and technology priorities.
Automation & Innovation:- Establish scalable business process automation standards, governance frameworks, and automation best practices.
- Analyze current workflows and identify automation opportunities to improve accuracy, compliance, productivity, and throughput.
- Design and implement automation solutions utilizing enterprise platforms and emerging technologies.
- Define automation integration touchpoints across enterprise applications to ensure seamless data flow and traceability.
- Evaluate and recommend emerging technologies, AI, workflow automation, and digital solutions that support business transformation initiatives.
- Deliver automation capabilities that improve productivity, reduce cycle times, enhance quality, and lower operational costs.
Process Improvement & Business Transformation:- Analyze current-state business processes and identify opportunities for standardization, simplification, and automation.
- Design future-state business processes, operating models, governance frameworks, and business capabilities.
- Develop process architectures, value streams, operational roadmaps, and transformation strategies.
- Support implementation of operational controls, monitoring mechanisms, and process performance metrics.
- Drive continuous improvement initiatives utilizing Lean, Six Sigma, and industry best practices.
- Align business process design with enterprise architecture and technology strategies
Project Delivery & Operational Support• Support project planning, roadmap development, milestone tracking and risk management activities.
• Coordinate project deliverables, resource planning, business readiness, and deployment activities.
• Assist project managers and business leaders in successful project execution.
• Monitor action items, decisions, dependencies, and project outcomes.
• Support implementation, cutover, go-live, hypercare, and operational transition activities.
• Drive change management, training, adoption, and business readiness effort
Testing & Validation• Develop test strategies, test scenarios, test scripts, validation plans, and acceptance criteria.
• Coordinate User Acceptance Testing (UAT), validation activities, and business verification processes.
• Document testing results and support issue identification, prioritization, and defect resolution.
• Ensure delivered solutions meet documented business requirements and compliance standards.
• Support validation of lifecycle activities in regulated environments.
Reporting & Documentation• Develop executive presentations, project status reports, dashboards, scorecards, and performance metrics.
• Maintain project documentation, requirements repositories, business procedures, and operational documentation.
• Track key performance indicators and communicate progress to leadership and stakeholders.
• Support internal audits, inspections, compliance reviews, and documentation requests.
• Prepare business and operational reports that support data-driven decision making.
Compliance, Security & Governance:- Ensure alignment of business processes with FDA, ISO 13485, MDR, and other applicable regulatory requirements.
- Ensure solutions comply with Abbott quality standards, cybersecurity requirements, and applicable regulations.
- Maintain policies, procedures, and documentation required for audits and inspections.
- Support validation, change control, and system lifecycle management activities.
- Promote governance standards that support sustainable, scalable, and compliant business processes.
- Collaborate with Quality, Regulatory, Privacy, and Information Security teams on risk mitigation strategies.
Minimum Qualifications & Education- Bachelor's degree in computer science, Engineering, or related field
- 10 years of experience in automation, IT business alignment, or Quality operations.
- Strong Business process defining experience including current and future process mapping state e.g business value propositions, etc.
- Knowledge of FDA regulations, ISO 13485, MDR, CAPA, Complaint Handling, and Quality Management Systems.
Preferred Qualifications- Post-Market Surveillance (PMS) and complaint handling functions knowledge.
- Exposure to cloud-based remote process automation (RPA) deployments like Automation Anywhere, UI Path etc.
- RPA certifications (e.g., UiPath Certified Developer, Automation Anywhere Advanced RPA Professional) preferred.
- Familiarity with Six Sigma, Lean, or other continuous improvement methodologies.
- Exposure to launching automation solutions in the Health Care or Med Device industry.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
The base pay for this position is
$130,700.00 - $261,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:IT Business Relationship Management
DIVISION:BTS Business Technology Services
LOCATION:United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
