Ai-Driven Digital Strategy Consultant (Remote) - Remote

BASE life science; Barcelona; Remote; EUR 68,000 - 115,000; Full time

Job summary

Veeva Systems is seeking an experienced consultant to lead MedTech Complaints implementations for customers worldwide. You will transform Complaints Management processes and configure our Vault-based solution for end-to-end MedTech tracking across the enterprise.

The role is remote and full-time, based in the EU or UK, with requirement of legal work authorization. You will collaborate with implementation teams and customer stakeholders to ensure successful adoption and ongoing improvement of the

Qualifications

• 5+ years of experience in Complaints Management for Medical Device.
• Strong FDA/EU MDR/IVDR knowledge and reporting.
• Experience leading implementation and IT operations as consultant or lead.
• Understanding of SaaS and GxP principles.
• Excellent verbal and written communication skills.

Responsibilities

• Review and analyse existing customer processes for implementation.
• Lead QMS Complaints implementation workstreams.
• Act as primary liaison between customers and teams.
• Analyse requirements to develop adoption roadmaps.
• Guide customers in adopting Vault and best practices.

Skills

Communication skills

Regulatory knowledge

SaaS knowledge

Tools

Veeva Vault

Job description

The Role Veeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s 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

• Review and analyse existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyse customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

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
• Experience with Data or Content Management applications

Compensation

Total compensation: 68,000 - 115,000 EUR The total compensation range listed here has been provided to comply with local regulations and represents a potential total compensation range for this role. Please note that actual total compensation may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position's total compensation may be composed of other types of compensation, such as variable bonus and/or stock bonus. #RemoteSpain