Description

Key Responsibilities

 Requirements and Process Analysis

- Elicit and document business and functional requirements fromQuality, Regulatory, and Operations stakeholders

- Map current-state and target-state quality processes, includingcomplaint handling, CAPA, nonconformance, change control, design control,audit, and training

- Write user stories, functional specifications, and acceptancecriteria

- Maintain requirements traceability from regulation toconfiguration to test

 Solution and Delivery Support

- Support configuration and design decisions on eQMS, PLM designcontrol, LIMS, MES, and electronic device history record platforms

- Support Computer Software Assurance and validation activities,including test scripts and traceability

- Facilitate workshops, backlog refinement, and user acceptancetesting with business and technical teams

- Raise and track defects, risks, and decisions through the deliverycycle

 Stakeholder and DomainSupport

- Act as the link between client quality teams and the deliveryorganization

- Translate FDA and ISO obligations into system requirements thedelivery team can build against

- Contribute to solution assets, process templates, and reusablerequirement catalogs for the Quality Vertical

 Required Qualifications andExperience

- 8 or more years as a Business Analyst in Life Sciences or MedicalDevice, or in a quality and regulatory function

- Strong domain knowledge of quality management systems and theregulations that shape them, including FDA 21 CFR Part 820 and the QualityManagement System Regulation, ISO 13485, 21 CFR Parts 210 and 211, 21 CFR Part11, and EU MDR with EUDAMED

- Working knowledge of eQMS, PLM design control, LIMS, MES, andelectronic device history record platforms

- Experience with requirements management, process mapping, and userstory writing

- Experience supporting validation under Computer Software Assuranceor GAMP 5

- Excellent written documentation and stakeholder communication

- FDA-related experience, such as remediation of warning letters orconsent decrees, is preferred

- Understanding of AI applications in quality and compliance is asignificant advantage

 Preferred Skills

- Prior experience with medical device or pharmaceuticalmanufacturers

- Exposure to quality and regulatory platforms such as TrackWise,ETQ, MasterControl, Veeva Vault Quality, PTC Windchill, STARLIMS, or Rimsys

- Familiarity with Agile delivery and backlog tools such as Jira orAzure DevOps

- Familiarity with Computer Software Assurance and GAMP 5 validation

- A business analysis certification such as CBAP or an IIBAcredential is an advantage

Key Skills

Education

Bachelor's degree