Senior MedTech QMS Complaints Consultant (Remote)

Veeva Systems, Inc.; California (MO); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Veeva Systems is seeking an experienced consultant to lead MedTech Complaints implementations across global customers. You will guide transformation of Complaints Management processes and configure our cloud-based Vault solution for enterprise use.

This remote, full-time role targets candidates with 5+ years in Complaints Management for Medical Device, with knowledge of FDA/EU MDR/IVDR and related regulations.

Qualifications

• Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor.
• 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 processes
• Knowledge of ISO 13485 and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• 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 Life Sciences Quality, Manufacturing, or Healthcare spaces
• Experience with Data or Content Management applications

Responsibilities

• Review customer processes to identify steps, gaps and requirements affecting implementation.
• Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions.
• Function as a primary customer liaison between implementation teams, customer stakeholders, and 3rd parties.
• Analyse customer requirements and new product features to develop adoption and roadmap plans.
• Guide customers in adopting Vault and best practices for post-implementation success.

Skills

Consulting leadership

MedTech Complaints

FDA/EU MDR

SaaS

GxP

Vault

Tools

Vault

Job description

Veeva Systems is seeking an experienced consultant to lead MedTech Complaints implementations across global customers. You will guide transformation of Complaints Management processes and configure our cloud-based Vault solution for enterprise use.

This remote, full-time role targets candidates with 5+ years in Complaints Management for Medical Device, with knowledge of FDA/EU MDR/IVDR and related regulations.