Nadira joined Qserve Group B.V. in 2017 as a QA/RA Consultant. With her MSc and PhD, she has gained a broad interdisciplinary knowledge in various fields of Biomedical Engineering, including medical Science, medical devices, software programming, tissue engineering and regenerative medicine. Besides her biomedical engineering background, she has good experience in designing, implementing, and executing various projects as well as training healthcare professionals.
The key expertise areas of Nadira include:
- Establishing and implementing quality management systems according to ISO 13485 standards
- Establishing and implementing MDSAP compliant quality management systems
- MDSAP & ISO 13485 auditing
- Experience with complaint and CAPA management
- Establishing GAP analysis tool against the upcoming European Medical Device Regulation (MDR) 2017/745
- Advice on the interpretation of the MDD, MDR and other legislation (FDA 21 CFR, Canada MDR, TGA, etc.) pertaining to medical devices (such as regulatory pathways, classification, etc.)
- Experience with Post-Market activities
- Scientific review and Clinical evaluation Clinical site assessment, qualification, and selection
- Monitoring at (international) sites
- Good clinical practice (GCP)
- Good Manufacturing Practice (GMP)
- Supporting with establishing technical documentation according to the MDD and MDR
- Supporting with global medical device registrations and establishing submission dossiers
- Performing risk management using ISO 14971
Nadira about working at Qserve:
"What I really enjoy is being a part of this team. I know that we have a positive influence on the work that we do. I have the freedom to fully develop myself in specific areas that are of interest to me. Qserve is a company that is really growing, and it is very motivating to be a part of that growth!"
Prior to Qserve, Nadira worked on her PhD. in Biomedical Engineering focusing on in vitro mucosa tissue models using functionalized electrospun biodegradable polymers.
Nadira has a master's degree in Biomedical Engineering from University of Strathclyde, UK and a PhD in Biomedical Engineering from University of Glasgow, UK.
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