Senior Consultant

Summary

Join Veeva Systems, a leading life sciences industry cloud company, as a MedTech Complaints Consultant. Lead implementations of Veeva’s MedTech Quality Management solutions for global customers, guiding the transformation of their Complaints Management processes and technology. Collaborate closely with Professional Services teams to ensure successful project delivery. Analyze customer needs, develop adoption roadmaps, and guide customers in utilizing Vault and industry best practices. This role requires strong project management skills, extensive experience in medical device complaints management, and a deep understanding of relevant regulations (FDA, EU MDR/IVDR, ISO 13485, etc.). Veeva offers a flexible work environment and a comprehensive benefits package.

Requirements

• 8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting
• 4+ 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 processes
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820 , 822, 806, EU GMP Annex 11
• Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
• Proven ability to work both independently and in teams in a dynamic, fast-moving environment
• Good understanding of SaaS and GxP principles
• Ability to quickly understand business requirements and design creative solutions
• Excellent verbal and written communication skills
• Experience in the Lifesciences Quality, Manufacturing, or Healthcare spaces
• Experience with Data or Content Management applications

Responsibilities

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Preferred Qualifications

• Veeva Vault implementation experience
• Management Consulting
• Change Management experience
• Field Action and Product Return experience
• Clinical Medical Device, Biologics, and SaMD experience

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program