Senior Consultant - Medtech QMS Complaints

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Veeva SystemsMedTech quality

The role is a remote, full-time role based in the EU or UK.Full-TimeSenior

Salary not disclosed

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Job Details

Experience: 5+ years of experience in Complaints Management for Medical Device
Required Skills: SaaSRisk Management

Have a proven track record leading implementation and/or IT operations as a consultant, business analyst, IT lead, or business sponsor.
Have 5+ years of experience in Complaints Management for Medical Device.
Demonstrate a strong understanding of FDA and EU MDR/IVDR requirements and reporting.
Understand the relationships among Complaint Handling, CAPA, Nonconformance, and Risk Management processes.
Know ISO 13485 and ISO 14971, FDA 21 CFR Parts 803, 820, 822, and 806, and EU GMP Annex 11.
Have a good understanding of SaaS and GxP principles.
Have experience in Life Sciences Quality, Manufacturing, or Healthcare.
Have experience with Data or Content Management applications.
Be able to understand business requirements quickly and design solutions.
Be able to work independently and as part of a team in a dynamic environment.

Review and analyse customer business processes to identify key process steps, gaps, and requirements that affect the implementation approach.
Lead QMS Complaints implementation workstreams for Veeva MedTech Quality Management solutions.
Serve as the primary customer liaison, managing communication among implementation teams, customer stakeholders, and third parties.
Analyse 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 customer success and continuous improvement.
Understand customer needs, translate requirements into solution designs, and configure the cloud-based MedTech Complaints solution.

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