Senior Consultant - Medtech QMS Complaints
Veeva Systems2 months ago
Dublin, IrelandSenior
Responsibilities
- Review and analyze customer business processes to identify process steps, gaps, requirements, and implementation impacts.
- Lead QMS Complaints implementation workstreams for Veeva MedTech Quality Management customers.
- Act as the primary customer liaison between implementation teams, customer stakeholders, and third parties.
- Analyze customer requirements and product features to develop adoption and enhancement roadmaps.
- Guide customers in adopting Vault and industry best practices through post-implementation programs and continuous improvement.
Requirements
- At least 5 years of experience in Medical Device Complaints Management.
- Proven experience leading implementation or IT operations as a consultant, business analyst, IT lead, or business sponsor.
- Strong understanding of FDA, EU MDR/IVDR requirements and reporting.
- Understanding of the relationship between Complaint Handling, CAPA, Nonconformance, and Risk Management processes.
- Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Parts 803, 820, 822, and 806, and EU GMP Annex 11.
- Understanding of SaaS and GxP principles.
- Experience in Life Sciences Quality, Manufacturing, or Healthcare.
- Experience with data or content management applications.
- Ability to understand business requirements and design creative solutions.
- Ability to work independently and collaboratively in a dynamic environment, with strong verbal and written communication skills.
Benefits
- Remote, full-time role based in the EU or UK
- Work Anywhere flexibility to work from home or in the office
- Candidates must have current legal authorization to work in the EU or UK; visa sponsorship is not anticipated
Tech Stack
Vault
Categories
Solutions Engineering
About Veeva Systems
Veeva Systems builds cloud software and data products for life sciences, including Veeva CRM and the Veeva Vault suite for clinical, regulatory, and quality operations. It sells subscriptions and services to biopharma and related companies to manage R&D, compliance, and commercial workflows. Founded in 2007 and headquartered in Pleasanton, California, Veeva is publicly traded on the NYSE and has operated as a Public Benefit Corporation since 2021.