Head of Regulatory Affairs and Quality Assurance
Descrizione dell'offerta
Our client is a clinical-stage R&D company developing innovative treatments for solid tumour oncology. We are seeking an experienced Medical Device Regulatory Affairs and Quality Assurance (QA) professional for an executive role. The position manages the QA Director and reports to the CEO.
Note: The role is remote, based in Milan, Italy, with travel required.
Key responsibilities:
- Develop and execute regulatory strategies and submissions for clearance and approval.
- Implement and maintain the company's quality management system (QMS).
- Support product development teams with regulatory guidance throughout the product lifecycle.
- Prepare or review technical documentation.
- Represent the company in regulatory, quality, scientific, and investor meetings.
Candidates should closely match the following criteria:
- Degree in a medical or scientific discipline (biology preferred).
- Significant experience in Regulatory Affairs and Quality Assurance of Class III implantable and/or combination medical devices.
- Experience leading RA/QA activities during pre-clinical and clinical stages for CE and FDA approval.
- In-depth knowledge of ISO 13485.
- Managerial experience is preferred.
- Strategic thinking and leadership skills.
- Excellent command of English.
- Willingness to travel to Italy.