Senior Consultant - Medtech QMS Complaints
Veeva Systems1 day ago
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 delivers the industry cloud for life sciences with software, AI, data, and business consulting. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,500 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com. Correspondence to new applicants and existing candidates will only come from an official @veeva.com email address.