Senior Consultant - Medtech QMS Complaints

📋 Description

• Lead QMS Complaints implementations for MedTech customers
• Act as primary liaison among teams, stakeholders, and 3rd parties
• Review processes, identify gaps, and define implementation approach
• Analyze requirements to drive adoption and roadmaps
• Guide post-implementation improvements and best practices

🎯 Requirements

• 5+ years in Complaints Management for Medical Device
• Experience as consultant, business analyst, or IT lead
• Strong knowledge of FDA, EU MDR/IVDR requirements
• Understand interplay of Complaint Handling, CAPA, Nonconformance, Risk
• Knowledge of ISO 13485 and ISO 14971; FDA 21 CFR Part 803, 820, 822, 806; EU GMP Annex 11
• Proven ability to work independently and in teams; SaaS and GxP aware

🎁 Benefits

• Remote role based in EU or UK
• Competitive compensation: 68,000 - 115,000 EUR
• Work with MedTech customers globally