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Veeva Systems

Builds cloud software for life sciences

Senior Consultant - Medtech QMS Complaints

Implementation & Technical Account ManagementConfirmed live in the last 24 hours
Full-timeRemote in UKNo salary listed

About the Job

Requirements

  • Proven track record leading implementation and/or IT operations as a consultant, business analyst, IT lead, and/or business sponsor.
  • At least 5 years of experience in Complaints Management for Medical Device.
  • Strong understanding of FDA and EU MDR/IVDR requirements and reporting.
  • Understanding of the relationship between Complaint Handling, CAPA, Nonconformance, and Risk Management processes.
  • Knowledge of ISO 13485 and 14971, FDA 21 CFR Parts 803, 820, 822, and 806, and EU GMP Annex 11.
  • 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 Life Sciences Quality, Manufacturing, or Healthcare.
  • Experience with data or content management applications.

Responsibilities

  • Review and analyze existing customer business processes and identify key process steps, gaps, and requirements that affect the implementation approach.
  • Lead QMS Complaints implementation workstreams at customers for Veeva’s MedTech Quality Management solutions.
  • Serve as the primary customer liaison, managing communication between implementation teams, customer stakeholders, and third parties.
  • Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps.
  • Guide customers in adopting Vault and industry best practices through post-implementation programs focused on holistic customer success and continuous improvement.

About the Company

Veeva Systems

Builds cloud software for life sciences

Veeva Systems builds cloud software and data products for pharmaceutical, biotechnology and other life sciences companies. Its applications support clinical trials, regulatory submissions, quality management, drug safety and commercial teams that work with healthcare professionals. Teams use the software to organize documents, track records and coordinate regulated work across departments on Veeva's Vault platform. Veeva earns revenue from subscriptions to its software and data products, alongside implementation, consulting and other professional services. Founded in 2007, Veeva Systems is headquartered in Pleasanton, California, United States.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Pleasanton, CA
Founded
2007

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