Ra/qa Officer
il y a 2 semaines
**RA/QA Officer**:
**QA/RA - Belgium**:
Department: QA/RA
Type: Permanent
Based: Hybrid
**Salary**: Competitive
Closing Date: 17/03/2024
Start Date: ?
IDS est l'un des principaux fournisseurs en solutions de diagnostic in vitro sur le marché des laboratoires cliniques. Nous développons, fabriquons et commercialisons des immunoessais innovants et des technologies d'immunoanalyse automatisées pour fournir de meilleurs résultats de diagnostiques aux patients.
Le site de Liège a été fondé en 1989 en tant que spin-off de l'Université de Liège et occupe actuellement 76 employés avec des fonctions variées opérationnelles, administratives ainis qu'en R&D ou contôle qualité. Il s'agit d'un centre d'excellence dans la production et le développement de kit de diagnostiques, d'analyses automatisées IDS et d'anciliaires à utiliser sur la gamme d'analyseurs IDS. Ici, nous produisons environ 170 000 kits par an et avons cinq équipes de R&D travaillant sur des projets liés à nos tests automatisés.
**Are you an experienced Regulatory Affairs professional looking to progress your career in an international, dynamic and innovative business?**
We have an excellent opportunity available for an experienced Regulatory Affairs professional to join our QA & RA team at our Liege site. In this role you will work collaboratively with an international team, cross functionally, to successfully manage regulatory affairs, including product registration, technical files, batch recalls and communication with national authorities. Additionally you will fulfill the role of Alternate PRRC as defined by Article 15 of IVDR 2017/746.
**Principle Accountabilities**:
- Carrying out gap analyses when new legislation, standards or guidelines are published or revised.
- Ensuring the implementation of new legislation, standards or guidelines and of new and amended requirements following their revision.
- Participate in updating and managing product CE marking files.
- Registering products and updating files (CE technical file, DHF).
- Ensure compliance with IVDR Regulation 2017/746 by the legal manufacturer of the products for which IDS SA is the European authorised representative.
- Centralising requests for standards for IDS Belgium, ordering standards and forwarding them to the requester.
- Ensuring the implementation of standards and regulations applicable to products, processes, safety and the environment.
- Exchanging information associated with regulatory activities and the marketing of products in new territories with the Boldon, Spello and Pouilly-en-Auxois sites.
- Participation to the interaction with regulatory and standards bodies.
- Write, review and keep up to date all documentation relating to Regulatory Affairs processes.
- Edit and publish Master Safety Datasheets (MSDS) for the IDS Liege site. Coordinate modifications of labels and Instruction For Use according the corresponding MSDS’s.
- Preparing regulatory training materials and training the staff concerned.
- Monitor KPIs, collect data to keep KPIs up to date, carry out trend analyses.
- Communicate to the line manager any needs in terms of material and human resources required to run the department
- Collect and analyse data
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