Project Manager
- Hiring Organisation
- GxPeople Global
- Location
- London Area, United Kingdom
deliverables. Coordinate logistics for bench testing, pre-clinical work, and international clinical study site readiness. Regulatory & Quality Compliance • Ensure all development activities align with ISO 13485, FDA (510k), and MDR design control requirements. Structure project activities to generate robust design verification and validation (V&V) evidence. Support document … device development. Track Record: Proven history of driving Class II/III medical devices through to regulatory submission. Regulatory Knowledge: Strong working knowledge of ISO 13485, design controls, and FDA 510(k)/CE-mark pathways. Tool Proficiency: Mastery of planning tools such as MS Project, Smartsheet, Jira ...