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Job Information

QA Vigilance Specialist

Information About this Role

Job Summary

Job Title: QA Vigilance Specialist

Salary: Highly competitive with full corporate benefits including pension, healthcare, subsidised canteen, on site gym & more!

Company Description

We’ve got an exciting opportunity as a QA Vigilance Specialist for a renowned global leader in orthopaedic medical technology. Our client offer the widest range of advanced technologies giving you the chance to work alongside the most cutting edge spinal products in the market.

Want a rewarding career? Our Client are a regular feature in Fortune Magazine’s 100 best companies to work for so you’ll be sure to get the best out of your workday & take your career to the next stage!

Job Description for the QA Vigilance Specialist:

The primary responsibility of the QA Vigilance Specialist is to ensure regulatory requirement compliance & ensure prevention of patient risks.

Duties and Responsibilities for the QA Vigilance Specialist includes:

  • Being the Division process owner for PFA & Holds
  • Working closely with manufacturing divisions & European Authorized representatives to review PFA reportibility
  • Collecting information requested by local Authorities, monitoring development with local RAQA managers & ensuring KPIs are met
  • Ensuring EEMEA complies with local vigilance applicable regulation
  • Supporting countries to get relevant information re technical & medical assessments from manufacturing divisions
  • Coordinating with OEM manufacturers, reviewing notification packages & advising on reportibility to C.A
  • Preparing weekly & monthly vigilance reports & RAQA monthly reports
  • Implementing processes for adverse event reporting for EEMEA countries outside of EU
  • Supporting the EEMEA QA Manager in QA related activities including reporting & auditing
  • Preparing & delivering vigilance training to EEMEA & India leaders, RAQA & distributors

 

Experience and Skills Required for the QA Vigilance Specialist include:

 

  • Previous involvement in an international medical device company & medical device regulation environment
  • Open minded & able to build relationships with colleagues in different countries & cultures
  • Excellent written & verbal communication skills
  • An abstract & analytical thinker
  • Organisational expertise with the ability to juggle multiple tasks & meet deadlines
  • Ability to influence senior colleagues
  • Determined & reliable with high standards for success
  • Bachelor degree in a technical or scientific field

Sound like you? Apply NOW! Don’t miss out on this career building opportunity as a QA Vigilance Specialist Today!

If you have any further queries regarding this role please call Tim on: 0203 800 0502

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We‘re a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Spaces. 

We are dedicated to finding the right opportunity for you.