Senior Consultant - Medtech QMS Complaints

📋 Description

• Review and analyse existing Customer business process and identify key process steps, gaps, and
• Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality
• Function as a Primary customer liaison managing communication between implementation teams
• Analyse customer requirements and new product features to develop customer adoption and enhancement
• Guide customers in adopting Vault and industry best practices as part of post-implementation

🎯 Requirements

• Proven track record leading implementation and/or IT operations as a consultant, business analyst
• 5+ years of experience in Complaints Management for Medical Device
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Proven ability to work both independently and in teams in a dynamic, fast-moving environment

🎁 Benefits

• Remote, full-time role based in the EU or UK with Work Anywhere flexibility
• Competitive compensation package