Clinical Regulatory Affairs Specialist

il y a 18 heures

Leuven, Belgique GC Europe Temps plein

**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 clinical evaluation under the Medical Device Regulation (MDR).
- Compliance with requirements for post-market surveillance (PMS) under the MDR.

**Main Tasks**:

- Preparing and/or updating clinical evaluation plans and reports (CERs).
- 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).
- Conducting clinical literature and vigilance database searches.
- Conducting PMCF studies (i.e. surveys) or supporting consultants conducting such studies for GC Europe.
- Implementing scientifically and statistically sound methods into study plans and data analyses
- 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 life science/engineering discipline.
- Knowledge of clinical dentistry. Previous experience as a dentist is a plus.
- At least basic knowledge of biostatistics.
- Excellent command of both written and spoken English (other languages are a plus).
- High flexibility in adapting to a fast-paced environment
- Knowledge of post-market activities and related documents, such as PMS plans, PSURs, PMCF plans and reports, SSCPs, CERs is a strong plus.
- Previous experience in clinical trials and/or medical writing 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
- Multicultural environment
- 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)

**Interested?**

**Contact person**:
**Katarzyna Dydak**
- HR Officer_

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