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 medical device Regulatory Affairs and Quality Assurance (QA) professional to join the team in this executive role. The role manages the QA Director and reports to the CEO of the company.
PLEASE NOTE the role is remote but the company is based in Milan, Italy and travel will be required.
Key responsibilities:
Responsible for the regulatory strategies and submissions necessary to obtain regulatory clearance and/or approval.
Coordinate the implementation and maintenance of the company\’s quality management system (QMS).
Support project teams during the development of new products and the product lifecycle providing guidance on the applicable regulatory requirements.
Prepare or review technical documentation.
Represent the company in regulatory, quality, scientific and investor meetings.
To be considered for the role, you must closely match the following criteria:
A degree in a medical or scientific discipline (biology is preferred).
Solid experience in Regulatory Affairs and Quality Assurance of class III implantable and/or combination medical devices.
Experience in leading RA/QA activities at a pre-clinical (essential) and clinical stage of product development for CE and FDA approval.
Detailed understanding of ISO 13485.
Managerial experience is preferred.
Strategic thinking and leadership skills.
Excellent English language is a must.
Ability to travel to Italy.
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