Job Summary
This role involves providing support for assigned clinical projects, ensuring product conformity to EU MDD or MDR regulations. Responsibilities include writing clinical evaluation plans and reports, participating in project groups, and assisting with clinical submissions.
Key Responsibilities:
* Preparing, writing, editing, and reviewing Instructions for use (IFUs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Plans (PMCFPs), and Summary of Safety and Clinical performance (SSCPs)
* Designing, conducting, and documenting systematic literature searches in medical databases
* Appraising, grading, analyzing, and writing up clinical data to establish acceptance criteria
* Knowledge of risk management processes and proposed and current global medical device regulations