Seeking an experienced Senior Clinical Research Associate to oversee clinical trials for medical devices. This role involves managing study activities, coordinating with site staff and teams, and ensuring compliance with ISO standards, FDA regulations, and EU MDR.
Key responsibilities include:
* Designing and writing protocols for preclinical and clinical studies
* Conducting literature reviews and MAUDE searches
* Creating and updating CEPs and CERs
* Supporting verification and validation studies
* Reviewing and qualifying new study sites
Requirements:
* 5+ years of experience in clinical studies for medical devices
* Strong knowledge of QMS, GCP, and GLP
* Fluent in English and local language
* Familiarity with device development from pre-clinical to commercial stage
This is an excellent opportunity for a seasoned professional to take on a leadership role in clinical research.