🕒 2 days ago
Leads multi-hospital safety and reliability consulting engagements, guiding healthcare leaders through HRO transformations, translating complex analytics into action, and developing client relationships and practice growth.
Senior Consultant - Medtech QMS Complaints
📅 Aug 12
Medtech Complaints ManagementQMS ImplementationMedical DeviceFDA Requirements
📜 Description
- Assess customer processes to identify key steps, gaps, requirements, and implementation impacts.
- Lead QMS Complaints implementation workstreams for MedTech Quality Management solutions.
- Serve as the primary liaison among implementation teams, customer stakeholders, and third parties.
- Develop customer adoption and enhancement roadmaps based on requirements and product features.
- Guide customers in adopting Vault and industry best practices for ongoing improvement.
🛠️ Requirements
- Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
- 5+ years of experience in Complaints Management for Medical Device
- Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
- Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes
- Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
- Proven ability to work both independently and in teams in a dynamic, fast-moving environment
- Good understanding of SaaS and GxP principles
- Ability to quickly understand business requirements and design creative solutions
- Excellent verbal and written communication skills
- Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces
✨ Benefits
- Work-from-home or office flexibility.
Full job description
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 (PBC), 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 Role
Veeva 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 Do
Requirements
Interviewing with Veeva
We value your time and believe in a transparent hiring process. Here is the process you can expect.
- A conversation with the hiring manager
- A practical case exercise
- A final conversation with our group's Senior Leader.
Compensation
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