Neval Ceren Gündogan

Performed imaging-based technical characterization using SEM (Scanning Electron Microscopy) and Confocal Microscopy in a regulated pharmaceutical R&D environment. Generated and maintained compliant technical documentation and structured datasets, ensuring traceability and accuracy. Managed documentation tracking and filing using SAP and TrackWise. Supported audit readiness and collaborated cross-functionally to maintain regulatory alignment.

Supported international product registrations through preparation and coordination of submission documentation. Maintained and updated technical files in QMS in compliance with ISO 13485 and EU MDR 2017/745. Conducted quality control reviews and managed documentation tracking and version control through PTC Windchill. Assisted in audit preparation and coordinated documentation activities across Regulatory Affairs, Quality, and R&D.

Developed Python-based data analysis pipelines (Pandas, NumPy, SciPy) for predictive system monitoring. Built automated workflows and basic visualization tools using HTML, CSS, and JavaScript. Strengthened analytical thinking, structured data handling, and technical problem-solving skills.

Focus areas: Medical Imaging, Biosensors, Diagnostics, Regulatory Aspects Master’s Thesis: High-Resolution Multi-Species Characterization of Intracranial and Medullary Microvasculature via Raster-Scan Optoacoustic Mesoscopy (RSOM/fRSOM) Technical Focus: Traceable data acquisition and analysis emphasizing reproducibility, documentation quality, and process reliability. Clinical Application: Insight into surgical workflows through observation of open-heart surgery at LMU Hospital.

Relevant Coursework: Circuit Analysis, Electronics, Microprocessors, Digital Signal Processing, Python Programming Bachelor’s Thesis: Development and Optimization of a Wireless ECG Monitoring System for Real-Time Cardiac Signal Acquisition Technical Focus: Structured engineering development, testing, and documentation with emphasis on safety- and quality-relevant requirements.