Medical Device Specialist Needed
About the Role:
* This is an exciting opportunity for a highly skilled professional to manage clinical trials outsourced to CRO's and support the development of innovative medical devices.
* The ideal candidate will have experience in coordinating clinical investigation activities, working with site staff, consultants, and teams as needed.
Main Responsibilities:
* Coordinate clinical trial activities, ensuring compliance with ISO standards, FDA regulations, EU MDR, and other applicable requirements.
* Develop and implement quality management systems to ensure high-quality data collection and reporting.
* Work collaboratively with cross-functional teams to design and execute clinical studies, including literature reviews and MAUDE searches for evaluations.
* Prepare and present study initiation and device training sessions.
Key Requirements:
* Strong knowledge of QMS, GCP, and GLP for medical devices and clinical studies.
* Understanding of Class III device regulations in EU, US, and globally (ISO 14155 & EU MDR 2017/745).
* 5+ years' experience in clinical studies for medical devices, preferably with cardiovascular experience.
* Fluent English language skills, with ability to communicate complex information effectively.
We Are Looking For:
* A highly motivated individual who can work independently and collaboratively as part of a team.
* A strong background in clinical research, with passion for medical devices.
We encourage you to apply if you have the necessary skills and qualifications.