Senior Consultant - Medtech QMS Complaints

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

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:

A conversation with the hiring manager

A practical case exercise

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: 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.