Our client is a clinical-stage R&D company that is developing an innovative treatment for Solid Tumour oncology.

They are now looking for an experienced R&D professional to join the team as Technical Director to lead the product design and development process. The main focus of the position will be ensuring the approval by regulatory authorities and QMS documentation to build the Design History File of the product. The position will manage small team remotely and 3rd party vendors.

The position is part of the leadership team and works closely with the CEO of the company.

Please note: the company is based in Milan, Italy and frequent travel will be required.

To be considered for the role you must closely match the following profile:          

• A degree in a medical, scientific or engineering discipline (biologics is preferred).
• Solid experience in the design and development of class III implantable and/or combination medical devices.
• Extensive experience in creating product verification and validation documentation – design history file.
• Project management experience.
• Detailed understanding of ISO 13485.
• Management of external partners and cross-functional teams.
• High level of technical and personal capabilities; a problem-solver.
• Ability to travel regularly to Italy or relocate.