MedTech QMS Complaints Senior Consultant (Remote)

Visa Hunt; United States; On-site; USD 122,000 - 162,000; Full time

Job summary

Veeva Systems is seeking an experienced Senior Consultant to lead MedTech QMS Complaints implementations across global customers. You will guide the transformation of our customers’ Complaints Management processes and configure Vault-based solutions for enterprise-wide use.

This remote, full-time role in EU/UK requires deep knowledge of regulatory requirements (FDA, EU MDR/IVDR) and a proven track record in SaaS implementations within Life Sciences quality systems.

Qualifications

• 5+ years in Complaints Management for Medical Device.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11.
• Experience with SaaS and GxP principles.
• Ability to work independently and in teams.
• Excellent verbal and written communication skills.
• Experience in Life Sciences Quality/Manufacturing/Healthcare.
• Experience with Data or Content Management applications.

Responsibilities

• Review and analyse existing Customer business process and identify key steps, gaps, and requirements.
• Lead QMS Complaints implementation workstreams for MedTech Quality Management solutions.
• Function as a Primary customer liaison between implementation teams and stakeholders.
• Analyse requirements and new product features to develop adoption roadmaps.
• Guide customers in adopting Vault and best practices for post-implementation success.

Skills

Consulting experience

Complaints Management

FDA/EU MDR/IVDR

ISO 13485 knowledge

GxP principles

SaaS know-how

Data/Content Mgmt

Life Sciences

Communication skills

Tools

Veeva Vault

Job description

Veeva Systems is seeking an experienced Senior Consultant to lead MedTech QMS Complaints implementations across global customers. You will guide the transformation of our customers’ Complaints Management processes and configure Vault-based solutions for enterprise-wide use.

This remote, full-time role in EU/UK requires deep knowledge of regulatory requirements (FDA, EU MDR/IVDR) and a proven track record in SaaS implementations within Life Sciences quality systems.