Senior Consultant - Medtech QMS Complaints

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation, legally bound to balancing the interests of customers, employees, society, and investors.As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.The RoleVeeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTech customers globally. In this role, you will guide the transformation of our customers’ Complaints Management processes and technology.As a member of our Professional Services team, you will be responsible for understanding our customers’ needs, translating requirements into solution design, and configuring our cloud-based solution for managing MedTech Complaints across the enterprise.This position is ideal for a proven software consultant with deep knowledge in Complaints Management in Medical Device.The role is a remote, full-time role based in the EU or UK. Qualified candidates must have current legal authorization to work in the EU or UK. Veeva Systems does not anticipate providing sponsorship for employment visa status for this position.What You’ll DoReview and analyse existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approachLead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Management solutionsFunction as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd partiesAnalyse customer requirements and new product features to develop customer adoption and enhancement roadmapsGuide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customerRequirementsProven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor5+ years of experience in Complaints Management for Medical DeviceStrong understanding of FDA, EU MDR/IVDR requirements and ReportingUnderstanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processesKnowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11Proven ability to work both independently and in teams in a dynamic, fast-moving environmentGood understanding of SaaS and GxP principlesAbility to quickly understand business requirements and design creative solutionsExcellent verbal and written communication skillsExperience in the Life Sciences Quality, Manufacturing, or Healthcare spacesExperience with Data or Content Management applicationsInterviewing with VeevaVeeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. #J-18808-Ljbffr