GC Europe NV is the European subsidiary of GC Corporation , a family-owned company with headquarters in Tokyo. It is one of the biggest suppliers of dental products with over 2300 employees all over the world and 4 production branches in Japan, the USA, China and Europe. We supply an entire range of consumer materials, equipment and facilities for dental offices and dental laboratories. GC is global market leader in glass ionomer cements and a well-established supplier in the sector of composites, cementation materials, impression materials as well as dental stones, investment materials and ceramics. GC has been recognized for over 25 years as a provider of consistently high product quality, featuring user-friendly handling and providing the best levels of customer service. We are currently looking within our Regulatory Affairs Department for an :
Clinical Regulatory Affairs Specialist
Mission :
- Ensuring that the organization meets at all times its legal obligations with regard to : Compliance with requirements for medical devices under the Medical Device Regulation (MDR), with a focus on Class III medical devicesCompliance with requirements for clinical evaluation under the MDRCompliance with requirements for post-market surveillance (PMS) under the MDR
Main Tasks :
Preparing and / or updating clinical evaluation plans and reports (CERs), with a focus on Class III medical devicesLiaising with internal and external stakeholders ensuring timely redaction of CERsPreparing and / or updating PMS plans, periodic safety update reports (PSURs), post-market clinical follow-up (PMCF) plans and reports, summaries of safety and clinical performance (SSCPs), with a focus on Class III medical devicesConducting clinical literature and vigilance database searchesConducting PMCF studies (i.e. surveys), cooperating with the Product Management Department when needed, or supporting consultants conducting such studiesImplementing scientifically and statistically sound methods into study plans and data analysesWhen required, participate in the design, management and reporting of clinical investigationsLiaising 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 research and / or medical writingAt least basic knowledge of biostatisticsVery good command of MS Office applications, especially Excel, PowerPoint, WordExcellent command of both written and spoken English (other languages are a plus)High flexibility in adapting to a fast-paced environmentKnowledge of clinical dentistry or orthopedics is a plusPrevious experience as a dentist is a plusKnowledge of post-market activities and related documents, such as PMS plans, PSURs, PMCF plans and reports, SSCPs, CERs is a strong plusKnowledge of MDCG guidance documents and ISO standards focusing on clinical aspects for medical devices is a plusWe offer you :
Challenging job in a growing international companyMulticultural environmentFull-time employment with a contract for an indefinite periodFlexible hours and possibility to work from homeCompetitive salary including benefits (meal vouchers, hospitalization and group insurance)