Overview In this role you will drive digital transformation of Post-Market Surveillance by aligning business needs with technology solutions. You will lead requirements, process mapping, and validation to enable compliant, automated complaint handling. You'll collaborate with Quality, Regulatory, Operations, and IT to deliver scalable automation that boosts accuracy, efficiency, and traceability. This is a hands-on, cross-functional leadership position with a strong focus on governance, change management, and measurable outcomes.
Compensation / Benefits- free medical coverage in HIP PPO
- retirement savings with high employer contribution
- tuition reimbursement
- FreeU education benefit
- great place to work recognized globally
- career development in an international company
Responsibilities- Gather, analyze, and document requirements, specifications, rules, and workflows
- Lead requirements workshops and stakeholder discussions
- Create business cases, process maps, use cases, and acceptance criteria
- Serve as primary liaison between business and IT for successful delivery
- Ensure requirements traceability and alignment with strategic objectives
- Coordinate with IT, vendors, and business teams for timely delivery
- Support UAT, validation, change management, and training
- Manage risks, dependencies, and stakeholder communications throughout projects
- Develop and implement automation standards, governance, and best practices
- Support testing strategies, validation plans, and lifecycle activities
- Produce executive reporting, dashboards, and performance metrics
- Assist with audits, compliance reviews, and documentation requests
- Ensure regulatory alignment (FDA, ISO 13485, MDR) and cybersecurity compliance
- Drive transformation initiatives using Lean, Six Sigma, and continuous improvement
- Support implementation, go-live, hypercare, and operational transition
- Monitor action items and project outcomes
- Promote governance to support scalable, compliant processes
Key requirements- Bachelor's degree in computer science, engineering, or related field
- 10 years of experience in automation, IT business alignment, or quality operations
- Strong experience in business process definition and current/future state mapping
- Knowledge of FDA regulations, ISO 13485, MDR, CAPA, complaint handling, and QMS
- Ability to align business processes with regulatory and quality standards
- Stakeholder management
- Excellent communication and facilitation skills
- Cross-functional collaboration
- Process mapping and business analysis
- Requirements management and UAT coordination
- Automation and RPA concepts; familiarity with enterprise platforms
