Quality Management/ Regulatory Affairs Specialist

  • Full Time
  • Germany
  • £80000


Gilbert Meher are currently searching for a Quality Management/ Regulatory Affairs Specialist, for an innovative medical device company with more than 30 years’ experience in the field of neurosurgery.

The Job

  • Developing and maintaining the existing quality management system, according to ISO 13485: 2016 and US FDA QSR
  • Responsible for regulatory projects and approvals in Germany and abroad
  • Planning and implementing audits
  • Co-ordinating departments, notified bodies and authorities (including BfArM, FDA, etc.)
  • Monitoring suppliers and service providers

The Candidate

  • Successfully completed technical or scientific studies
  • Minimum of 3 years Quality Management/ Regulatory Affairs experience
  • Knowledge of the approval of medical devices (ISO 13485, MPG, MDR, FDA, etc.)
  • Competent in German and English, both spoken and written
  • Sound MS Office knowledge

For more information about this role, please contact Abigail Prudhoe at abigail.prudhoe@gilbertmeher.com or call +44 113 457 5275


Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.