Senior Consultant - Medtech QMS Complaints

Veeva Systems, Inc.; California (MO); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Veeva Systems is seeking an experienced consultant to lead MedTech Complaints implementations across global customers. You will guide transformation of Complaints Management processes and configure our cloud-based Vault solution for enterprise use.

This remote, full-time role targets candidates with 5+ years in Complaints Management for Medical Device, with knowledge of FDA/EU MDR/IVDR and related regulations.

Qualifications

• 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, FDA21CFR 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

Responsibilities

• Review customer processes to identify steps, gaps and requirements affecting implementation.
• Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions.
• Function as a primary customer liaison between implementation teams, customer stakeholders, and 3rd parties.
• Analyse customer requirements and new product features to develop adoption and roadmap plans.
• Guide customers in adopting Vault and best practices for post-implementation success.

Skills

Consulting leadership

MedTech Complaints

FDA/EU MDR

SaaS

GxP

Vault

Tools

Vault

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, 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

• 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 13485and 14971, FDA21CFR 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

Interviewing with Veeva

Veeva’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 [e-mail].