Ra/qa Officer
il y a 2 semaines
RA/QA Officer:
QA/RA - Belgium:
IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
The Liege site was founded as a spin off from the University of Liege in 1989 and now houses 75 employees spread across operations, R&D and administrative functions.
It is centre of excellence for the production and development of IDS automated assays and ancillaries for use on the IDS range of analysers.
Here, we produce around 170,000 assay kits per year and have five R&D teams working on development projects related to automated assays.
Job Purpose
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.Principal 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 PouillyenAuxois 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 for the Post Market Surveillance (PMS) review.
- Play an active role in improving processes
- Carry out and monitor internal audits within the internal audit team.
- Act as a facilitator during audit from Regulatory Authorithies and Notified Bodies.
Skills, Knowledge and Experience
Qualifications
Scientific Master's degree (chemistry, biology, biochemistry, biotechnology, pharmacy or similar) plus 1 year industry experience.
OR
Science-oriented bachelor's degree, supplemented with at least 4 years' experience in a quality environment.
Skills & Knowledge
- Quality standards (EN ISO 13485, ISO 9001, ISO 1
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