Xeltis BV is looking for a skilled and driven Clinical Specialist to work in its enthusiastic team, sustaining the clinical realization of Xeltis’ revolutionary restorative medical devices.

Xeltis is a clinical stage medical device company with the world’s most advanced polymer-based platform of restorative cardiovascular devices. Xeltis’ devices naturally evolve into living blood vessels or heart valves within the body through patient’s own tissue.

The company has a young team of 40 employees from all over the world. “Improving patients’ lives” is what drives us to work with joy on a daily basis.

Who are we looking for?

We are looking for a Clinical Specialist that will collaborate on our ongoing Clinical Trials by building a thorough understanding of our revolutionary restorative medical devices and by supporting their implantation.

Activities include:

• Supporting sites, physicians and other Health Care Professionals (HCPs) with study related procedures and first implants of the Xeltis study devices
• Providing adequate clinical training to the treating physicians and nurses
• Actively collaborating with clinical trial sites and local principal investigators in patient recruitment and selection
• Supporting site identification and selection
• Supporting CROs and/or clinical sites during study start-up, enrollment, follow-up and close-out phase
• Reviewing clinical data and managing SAE documentation and reporting
• Reviewing interim and final reports in close cooperation with the Clinical Affairs team at Xeltis and the CRO
• Collaborating closely with the R&D, QA and Clinical Affairs teams and with external consultants, such as but not limited to CROs and/or core labs
• Professionally collaborating with investigators and other study site HCPs
• Assisting Xeltis’ non-clinical departments in meeting company quality, regulatory, engineering, marketing and sales goals and objectives, as needed and where appropriate
• Providing periodic updates or reports on the current status of clinical trials to senior management
• Managing administration and being responsible for study status reports, essential documents, and accurate study files

Pre-requisites:

• Associate’s or Bachelor’s Degree in nursing, biomedical engineering, or science
• 3+ years’ experience in nursing, physician assistant, cardiopulmonary technician positions
• 2+ years’ experience in clinical specialist positions, with experience with Class III medical devices
• Familiar with European and US regulations, specifically MDR and/or other relevant standards
• Demonstrated leadership and problem-solving skills
• Demonstrated clinical trial enrolment skills a plus
• Experience in preparing and reviewing relevant documentation for ethics committees, competent authorities and regulatory agencies in cooperation with CROs, clinical and regulatory affairs
• Ability to successfully interact with clinical sites, investigators and hospital study nurses
• Excellent communication skills with fluency in English
• Speaking another EU language a plus
• Ability and motivation to travel extensively (>75%)
• Knowledge about clinical studies and relevant regulations/guidelines

The position is full-time. For more information and to submit your CV and motivational letter, please contact: recruitment@xeltis.com