Clinical Scientist
Clinical Scientist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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:
- Masters 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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
