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Clinical Regulatory Affairs Specialist

il y a 1 mois

Leuven, Flandre, Belgique TN Belgium Temps plein

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Clinical Regulatory Affairs Specialist, Flemish BrabantClient:

Gc Europe Ag

Location:

Flemish Brabant

Job Category:

Other

EU work permit required:

Yes

Job Reference:

70e83812881d

Job Views:

3

Posted:

06.03.2025

Expiry Date:

20.04.2025

Job Description:

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 a 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 a:

Clinical Regulatory Affairs Specialist

Mission:

  • Ensuring that the organization meets at all times its legal obligations regarding compliance with requirements for medical devices under the Medical Device Regulation (MDR), with a focus on Class III medical devices, compliance with requirements for clinical evaluation under the MDR, and compliance 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 devices.
  • Liaising with internal and external stakeholders ensuring timely redaction of CERs.
  • 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.
  • Conducting clinical literature and vigilance database searches.
  • Conducting PMCF studies (i.e., surveys), cooperating with the Product Management Department when needed, or supporting consultants conducting such studies.
  • Implementing scientifically and statistically sound methods into study plans and data analyses.
  • When required, participate in the design, management, and reporting of clinical investigations.
  • Liaising with Sales, Marketing, and QA Departments to ensure PMS activities are conducted under regulatory supervision.
  • Ensuring that relevant CE marking documents (including product technical files) are complete and up to date.
  • Performing vigilance activities as required.

Requirements:

  • Master's degree/Diploma in Dentistry, Chemistry, Biology, or equivalent medical/life science/engineering discipline.
  • Previous hands-on experience in clinical research and/or medical writing.
  • At least basic knowledge of biostatistics.
  • Very good command of MS Office applications, especially Excel, PowerPoint, Word.
  • Excellent command of both written and spoken English (other languages are a plus).
  • High flexibility in adapting to a fast-paced environment.
  • Knowledge of clinical dentistry or orthopedics is a plus.
  • Previous experience as a dentist is a plus.
  • Knowledge of post-market activities and related documents, such as PMS plans, PSURs, PMCF plans and reports, SSCPs, CERs is a strong plus.
  • Knowledge of MDCG guidance documents and ISO standards focusing on clinical aspects for medical devices is a plus.

We offer you:

  • Challenging job in a growing international company.
  • Full-time employment with a contract for an indefinite period.
  • Flexible hours and possibility to work from home.
  • Competitive salary including benefits (meal vouchers, hospitalization, and group insurance).
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