Description
An innovative company that is in the process of incorporating the legal manufacture of all of their devices in house (Class III) are looking for a Regulatory Affairs Independent Consultant / Freiberufler for their Berlin office.Regulatory Affairs - Independent Consultant / Freiberufler (M/W/D)
The company is also working on the MDR standards to ensure their system is aligned therefore looking for someone to assist for 6 months initially in Berlin. The position is looking for a Independent Consultant to;
· Implement a MDR GAP analysis
· Work with Single Devices and Device Registration in Europe and Asia (optional)
· Have FDA experience with technical documentation
· Have strong MDD and AIMDD (preferred) Knowledge
Preferentially the Consultant would have experience in:
· Class III / Class IIb / Class I Software
· Electrical equipment's, MRI, CT etc.
· From a Bio-medical Engineering / Mechanical engineering / Electrical Engineering Background
EPM is in the process of transitioning alongside its parent company -Phaidon International- to set up offices in Berlin to ensure it is offering a closer service to clients and candidates.
Isabel Kennedy - will be spearheading this growth and is directly responsible for this position.
If of interest please apply with your most up to date CV - and we will arrange a time for a confidential introduction.