Senior Regulatory Affairs Manager
Based in Villingen-Schwenningen
Our client is a mid-sized international manufacturer of non-active medical devices, offering implants from Class IIb - Class III. The company has offices in Germany and the USA with over 100 years of experience in innovative surgical solutions for the medical industry.
To support further product releases and strengthen the team, they are searching for a senior specialist to be focused on regulatory activities in Europe and the upcoming MDR.
· Control and implementation of activities for successful approval of our medical devices in Europe and the USA
· Creation and maintenance of product files
· Participation in the further development of the quality management system
· Creation of the development accompanying documentation in the development process
· Completed engineering studies
· 4+ years of experience in the regulatory approvals of medical devices in EU, FDA as a bonus
· Very good knowledge of English and German
· Structured and independent way of working, as well as strong communication and team skills
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.
+44 208 638 5376