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.
- 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
- 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 firstname.lastname@example.org 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.