Company Description
About Traferox:
Traferox is a medical technology company transforming the field of organ transplantation. Our mission is to improve transplant outcomes and access through innovative preservation and perfusion technologies grounded in rigorous science. We are the creators of the FDA-cleared X°Port Lung Preservation System and pioneers in next generation lung perfusion systems, setting new standards in donor organ care.
Job Description
Union: Non-Union
# of Vacancies: 1
Department: Clinical Development
Reports to: Director of Clinical Development
Hours: 37.5 hours per week
Status: Permanent full-time
Position Summary
We are seeking a dynamic and detail-oriented
Clinical Scientist to join our growing team. This role is central to the clinical and scientific advancement of our organ transplant device portfolio. The successful candidate will support regulatory submissions, provide customer-facing field support and training, and contribute to research and development through literature reviews and pre-clinical initiatives. This is a cross-functional position involving collaboration with clinical, regulatory, R&D, and commercial teams.
Key Responsibilities
Regulatory Support:
- Prepare and contribute to clinical and scientific sections of regulatory submissions, including IDE, PMA, 510(k), and Health Canada filings.
- Coordinate with clinical and regulatory teams to ensure scientific accuracy and completeness of submitted documentation.
- Interpret clinical and pre-clinical data to support claims of safety and effectiveness.
Customer-Facing Support & Training
- Deliver clinical education and technical training to transplant teams and procurement organizations on the use of Traferox products.
- Provide on-site or virtual case support for organ retrieval and transplantation procedures.
- Serve as a scientific liaison to clinical partners, ensuring appropriate use and understanding of our technologies.
Scientific Research & Pre-Clinical Support
- Conduct comprehensive literature reviews to inform R&D, regulatory, and clinical initiatives.
- Assist in protocol development and data analysis for pre-clinical studies.
- Draft and contribute to scientific publications, conference abstracts, and presentations.
Qualifications
Qualifications:
- Master’s or Ph.D. in Biomedical Sciences, Physiology, Pharmacology, or a related field.
- Familiarity with regulatory standards (FDA, Health Canada, ISO) and medical device development lifecycle.
- Strong understanding of organ transplantation and/or ex vivo organ support systems.
- Excellent written and verbal communication skills.
- Experience in scientific writing and presentation.
- Willingness and ability to travel throughout North America (up to 30%) for customer support and training.
Preferred Qualifications
- One or more years of experience in a clinical or scientific role in the medical device or transplant field.