Clinical Regulatory Affairs Specialist

GC Corporation was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products. Since 1972 GC Europe NV, our European Headquarter is located at the Researchpark Haasrode in Leuven (Belgium). GC Europe NV supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East.We are currently looking for a:Clinical Regulatory Affairs SpecialistMain responsibilities:Supporting the organization in the design, management and reporting of clinical investigationsEffectively managing interactions with clinical research organizations together with relevant internal stakeholdersPreparing and/or updating clinical evaluation plans and reports (CERs)Liaising with internal and external stakeholders ensuring timely redaction of CERsConducting systematic clinical literature searches and appraising retrieved articlesConducting post-market clinical follow-up (PMCF) studies (i.e., surveys) in cooperation with the Product Management DepartmentImplementing scientifically and statistically sound methods into study plans and data analysesPreparing and/or updating post-market surveillance (PMS) plans, periodic safety update reports (PSURs), PMCF plans and reports, summaries of safety and clinical performance (SSCPs)Liaising with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervisionEnsuring that relevant CE marking documents (including product technical files) are complete and up-to-datePerforming vigilance activities as requiredRequirements:Master’s degree/Diploma in Dentistry, Chemistry, Biology or equivalent medical/life science/engineering disciplinePrevious hands-on experience in clinical researchKnowledge of applicable regulations and standards in clinical researchVery good command of MS Office applications, especially Excel, PowerPoint, WordExcellent command of both written and spoken English (other languages are a plus)Attention to detailHigh flexibility in adapting to a fast-paced environmentNice to have:Previous experience in clinical monitoringKnowledge of clinical dentistry or orthopedicsKnowledge of biostatisticsKnowledge of post-market activities and related documents, such as PMS plans, PSURs, PMCF plans and reports, SSCPs, CERsWe offer you:Challenging job in a growing international company.Multicultural environment.Full time employment with a contract for an indefinite period.Flexible hours, and opportunity to work from home (fixed 2 days per week)Competitive salary including benefits (meal vouchers, hospitalization and group insurance).Interested?Don’t hesitate to send your CV and motivational letter to hr.gce@gc.dentalIn case of questions, please contact our HR department through +32 16 74 13 18 GC is an equal opportunity employer that evaluates applicants regardless of their race, nationality, gender, age or disability.We welcome candidates from all backgrounds, and actively promote diversity in the workforce.For our company's recruitment privacy notice, please visit this link