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Veeva Systems, a public benefit corporation and leader in industry cloud for life sciences, seeks an experienced Senior Consultant to lead MedTech Complaints implementations for customers globally. You will guide the transformation of customers' Complaints Management processes and technology, working as part of the Professional Services team.
Key responsibilities include reviewing and analyzing customer business processes to identify gaps and requirements; leading QMS Complaints implementation workstreams for Veeva's MedTech Quality Management solutions; serving as the primary customer liaison managing communication between implementation teams, stakeholders, and third parties; analyzing customer requirements and new product features to develop adoption and enhancement roadmaps; and guiding customers in adopting Vault and industry best practices for post-implementation success.
You will need 5+ years of experience in Complaints Management for Medical Devices, with a proven track record leading implementations, IT operations, or serving as a business analyst or IT lead. Strong understanding of FDA, EU MDR/IVDR requirements, and reporting is essential. You should be knowledgeable in ISO 13485 and 14971, FDA 21CFR Parts 803, 820, 822, 806, and EU GMP Annex 11. Experience in Life Sciences Quality, Manufacturing, or Healthcare is required. You must understand the relationships between Complaint Handling, CAPA, Nonconformance, and Risk Management processes, and have familiarity with SaaS and GxP principles. Excellent communication skills, ability to work independently and collaboratively, and experience with Data or Content Management applications are important. Candidates must have current legal authorization to work in the EU or UK; visa sponsorship is not available.