Senior Consultant - Medtech QMS Complaints

Veeva Systems, Inc.; Dublin; Hybrid; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Work Anywhere

Job summary

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

This remote, full-time role is based in the EU or UK, requiring current authorization to work in the EU/UK. You will collaborate with Professional Services, drive adoption, and ensure post-implementation success for life sciences customers.

Qualifications

• Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or 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.
• Ability to work both independently and in teams in a fast-moving environment.
• Good understanding of SaaS and GxP principles.
• Ability to translate business requirements into creative solutions.
• Excellent verbal and written communication skills.
• Experience in Life Sciences Quality, Manufacturing, or Healthcare spaces.

Responsibilities

• Review and analyse existing customer processes, identify gaps and requirements for implementation.
• Lead QMS Complaints implementation workstreams for MedTech Quality Management solutions.
• Serve as primary liaison between implementation teams, customers, and third parties.
• Analyse requirements and features to develop adoption and enhancement roadmaps.
• Guide customers in adopting Vault and best practices post-implementation for ongoing success.

Skills

Lead implementations

Complaints management

MedTech knowledge

FDA/EU MDR

GxP

SaaS familiarity

Data/Content management

Communication (verbal/written)

Independent work

Tools

Veeva Vault

Cloud-based SaaS

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

We value your time and believe in a transparent hiring process. Here is the process you can expect.

• Follow the application process and submit your resume.
• Within 3 days, you will receive a link to a personality assessment administered by a third party.
• Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
• If moving to the interview stage, the process is as follows:
  1. A conversation with the hiring manager
  2. A practical case exercise
  3. A final conversation with our group's Senior Leader.
• Once all interviews are complete, the manager will be in touch with a final decision.

Compensation

• Total compensation: 90,000 - 150,000EUR
• 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.

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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].