Our client is a clinical-stage R&D company that is developing an innovative treatment for solid tumour oncology.
We are looking for an experienced R&D professional to join the team as Product Development Associate Director. The role will be responsible for rapidly building and managing all aspects of the Design History File (technical documentation) for the company’s Class III medical devices, to enable the company to rapidly progress to the clinical evaluation stage. This role ensures compliance with regulatory requirements and supports the product development process by documenting the design and development activities per the company’s QMS. The role collaborates with the company’s small team and 3rd party suppliers/vendors.
The company has a platform technology and targets multiple indications meaning that once the DHF for the first indication has progressed, development will continue on new indications.
The position reports to the Head of Product Development and has no team.
PLEASE NOTE the company is based in Milan, Italy and once/ twice a month travel will be required.
Requirements:
· Individual contributor
· A degree in a medical, scientific or engineering discipline
· Solid hands-on experience in creating and managing DHF/technical documentation for class II or class III implantable and/or combination medical devices.
· Proven ability to design and formulate scientific studies for verification and validation of Class II-III medical devices.
· Strong understanding of FDA & MDR regulations, ISO 13485, ISO 14971 and other relevant standards
· Project and task management experience
· Management of external partners and cross-functional teams
· High level of technical and personal capabilities; a problem-solver
· Excellent command of English language is a must
· Ability to travel when necessary
