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