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:
1. 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:
2. Preparing and/or updating clinical evaluation plans and reports (CERs), with a focus on Class III medical devices
3. Liaising with internal and external stakeholders ensuring timely redaction of CERs
4. Preparing 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 devices
5. Conducting clinical literature and vigilance database searches
6. Conducting PMCF studies (i.e. surveys), cooperating with the Product Management Department when needed, or supporting consultants conducting such studies
7. Implementing scientifically and statistically sound methods into study plans and data analyses
8. When required, participate in the design, management and reporting of clinical investigations
9. Liaising with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision
10. Ensuring that relevant CE marking documents (including product technical files) are complete and up to date
11. Performing vigilance activities as required
Requirements:
12. Master’s degree/Diploma in Dentistry, Chemistry, Biology or equivalent medical/life science/engineering discipline
13. Previous hands-on experience in clinical research and/or medical writing
14. At least basic knowledge of biostatistics
15. Very good command of MS Office applications, especially Excel, PowerPoint, Word
16. Excellent command of both written and spoken English (other languages are a plus)
17. High flexibility in adapting to a fast-paced environment
18. Knowledge of clinical dentistry or orthopedics is a plus
19. Previous experience as a dentist is a plus
20. Knowledge of post-market activities and related documents, such as PMS plans, PSURs, PMCF plans and reports, SSCPs, CERs is a strong plus
21. Knowledge of MDCG guidance documents and ISO standards focusing on clinical aspects for medical devices is a plus
We offer you:
22. Challenging job in a growing international company
23. Multicultural environment
24. Full-time employment with a contract for an indefinite period
25. Flexible hours and possibility to work from home
26. Competitive salary including benefits (meal vouchers, hospitalization and group insurance)