Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
My client is a multinational medical devices company, operating from the Netherlands.
As a clinical scientist you will be responsible for clinical evaluation and documentation of product efficacy and safety, claims and intended use for various medical devices for home use. You will investigate the safety and efficacy of devices, using data from the literature and potentially data from clinical studies.
Perform clinical evaluations (and, if applicable, studies) in compliance with MEDDEV, FDA, GCP, ICH and internal regulations, procedures and guidelines.
Compile clinical evaluation reports for claims substantiation in compliance with timelines.
Review clinical evaluation reports and documentation of suppliers & contribute to relevant documentation such as user instructions and communication materials.
Comply with project standards and specifications following internal and regulatory guidelines.
PhD, preferably in life sciences.
Proven knowledge of GCP, ICH guidelines, FDA regulations as well as EU regulations.
2+ years of experience in clinical science.
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