Note: The job is a remote job and is open to candidates in USA. USDM Life Sciences is a consulting company that supports regulated biotech, medical device, and pharmaceutical organizations with GxP technologies and business processes. The Senior Business Systems Analyst will support business and technology initiatives in a regulated medical-device environment by translating business needs into requirements, improving QMS processes, and collaborating with quality, regulatory, business, and IT stakeholders.
Responsibilities
- Partner with Quality, Regulatory, Complaints, Operations, and IT stakeholders to understand business objectives and define practical system solutions
- Elicit, document, and validate business, functional, and system requirements
- Analyze current-state and future-state QMS processes and identify opportunities for improvement
- Support requirements and process work related to complaints management, investigations, escalation, workflows, and reporting
- Facilitate stakeholder interviews, workshops, process mapping, and fit-gap assessments
- Translate business requirements into user stories, functional specifications, use cases, acceptance criteria, and process documentation
- Collaborate with technical teams, vendors, and project managers throughout solution design, development, testing, and implementation
- Support test planning, test-case development, user acceptance testing, defect triage, and business readiness activities
- Assess impacts of system or process changes across quality, regulatory, and operational functions
- Maintain traceability between business needs, requirements, test evidence, and delivered functionality
- Communicate status, risks, decisions, and dependencies clearly to project and business leadership
Skills
- • Master's Degree preferred
- • 10+ years of experience as a Business Analyst, Business Systems Analyst, or comparable role
- • Demonstrated experience supporting QMS processes and systems in a regulated environment, preferably medical devices or life sciences
- • Strong requirements elicitation, process analysis, documentation, and stakeholder-management skills
- • Experience working across business and IT teams on enterprise system implementations, enhancements, or integrations
- • Ability to work independently, manage competing priorities, and operate effectively in a fast-moving environment
- • Strong written and verbal communication skills
- • Experience supporting validation, testing, change control, or other regulated-system delivery activities
- • Direct experience with complaints management processes or complaint-management systems
- • Experience with TrackWise, Teamcenter, or other enterprise QMS/PLM platforms
- • Experience in medical-device quality, post-market surveillance, CAPA, nonconformance, or change control processes
- • Familiarity with computer system validation, data integrity, and regulated SDLC practices
- • Experience supporting transitions, migrations, integrations, or modernization of legacy quality systems
- • Bachelor's degree in Computer Science or Information Systems or related field
Benefits
- Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
- Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.
- Full and part-time employees may be eligible for paid time off.
- All employees are eligible for USDM's rewards and recognition program.
Company Overview
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