Senior Consultant – MedTech QMS Complaints

About the role

Veeva is seeking an experienced Senior Consultant to lead MedTech QMS Complaints implementations for its global customers. You will guide the transformation of complaints management processes and configure Veeva’s cloud‑based solution across the enterprise.

Key responsibilities

• Review and analyse existing customer business processes, identifying gaps and requirements that shape the implementation approach.
• Lead QMS Complaints implementation workstreams for Veeva’s MedTech Quality Management solutions.
• Act as the primary customer liaison, managing communication between implementation teams, customer stakeholders, and third parties.
• Analyse customer requirements and new product features to develop adoption and enhancement roadmaps.
• Guide customers in adopting Vault and industry best practices as part of post‑implementation programs focused on continuous improvement.

Required profile

• Proven track record leading implementation or IT operations as a consultant, business analyst, IT lead, or business sponsor.
• 5+ years of experience in Complaints Management for Medical Devices.
• Strong understanding of FDA, EU MDR/IVDR requirements and reporting.
• Knowledge of the relationship between Complaint Handling, CAPA, Non‑conformance and Risk Management processes.
• Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Parts 803, 820, 822, 806, and EU GMP Annex 11.
• Ability to work independently and collaboratively in a fast‑moving environment.
• Good understanding of SaaS and GxP principles.
• Excellent verbal and written communication skills.
• Experience in Life Sciences Quality, Manufacturing, or Healthcare domains.
• Experience with data or content management applications.

Required skills

• Veeva Vault configuration and administration.
• ISO 13485 and ISO 14971 standards.
• FDA 21 CFR Parts 803, 820, 822, 806 compliance.
• EU MDR/IVDR regulatory knowledge.
• EU GMP Annex 11 familiarity.
• SaaS cloud‑based solution expertise.
• GxP principles.