Job Purpose (Role Definition):
To provide support to the clinical compliance team, who are responsible for undertaking clinical evaluations, providing support to the Research and Development and Regulatory Affairs teams in new product development and maintenance of existing products.
To support the Engineering department in the administrative functions of the department.
Main Duties and Responsibilities
Clinical Compliance
1. Following group processes for Clinical Evaluation (CER), ensuring compliance with MDR, FDA requirements and other relevant jurisdictions.
2. Creation and maintenance of documentation for technical files: CEP and CER.
3. Maintain the highest ethical, clinical and scientific standards, ensuring the safety and well-being of all trial participants and good/rigorous scientific practice.
4. Maintain surveillance of clinical publications of relevance and disseminate appropriately.
5. Maintain surveillance of the clinical research landscape of ours and competitor products.
6. Ensure all clinical references on marketing material are appropriate and referenced correctly.
7. Additional administrative duties when necessary.
8. Maintain compliance with the Company’s quality/business management system at all times.
Management Responsibilities
None
#J-18808-Ljbffr