Senior RA/QM Manager

(Senior) RA/QM Manager (m / w / d)

 

Based in Munich

 

My client is a highly innovative company who are producing a Class III cardiovascular implantable device and are searching for a Senior RA/QM position to support the successful growth of the company and smooth market access for the device. The company are based in Central Munich and are well supported having recently received a €25million investment - it’s a very exciting opportunity to support a life-saving device reaching the market successfully and being involved in MDR certification and creating a QMS to ISO 13485 compliance!

 

Your Responsibilities:

  • Strategic preparation and processing of global regulatory approvals for market-leading medical products
  • Device launches in EU/USA under the MDR and FDA
  • Management of the technical file documentation for international approvals in the EU and US
  • Collaborate on risk management for medical devices under ISO 14971
  • Continuous improvement and maintenance of the QMS in accordance with ISO 13485
  • A close partnership with other departments for a quick and efficient product launch in multiple markets

 

Experience Required:

  • Degree educated in scientific studies or engineering
  • 2-4 years of experience in regulatory affairs or quality management at a medical device company
  • Working knowledge of the MDD/MDR
  • Fluent in German, with very good spoken and written English
  • Experience working with ISO 13485

 

Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

Rebecca.Stevens@Adaptivelifescience.com

+44 208 638 5376