Hamlyn Williams has partnered with a Medical Technology company based in Munich that is in a Major phase of growth and looking for a Regulatory Affairs and Clinical Research Manager.

The role will involve:

Taking a leading role in regulatory affairs and quality management
Be responsible for the creation and maintenance of technical documentation for medical devices (SaMD, Class IIa) ensuring continued regulatory compliance with (EU) 2017/745 (MDR)
Contribute to the clinical evaluation of our software products
Identify and evaluate risks in our software systems according to ISO 14971 to reduce productrelated risks to a minimum
Setup and implement multi-centre clinical research and validation studies and projects

As a Regulatory Affairs and Clinical Project manager you will need:

Experience in clinical research / project management7
Technical understanding and a strong interest in IT, medical device software and artificial
intelligence
Excellent organizational, analytical, project management skills
Experience within Regulatory Affairs within the Medical device space
German speaking

Job