
M.Sc. Medical Engineering Student
Hadieh Ghanbarian
Focus: Quality Management (QMS) & Regulatory Affairs
About
I am a Medical Engineering Master's student (M.Sc.) looking to start a career in Quality Management (QM) or Regulatory Affairs (RA).
While my university studies focus on Medical Image and Data Processing, I have developed a strong interest in the regulatory framework that ensures these technologies are safe. I want to apply my technical background, specifically my understanding of software concepts and data, to the field of Quality Management.
To prepare for this path, I am actively building my knowledge of ISO 13485 and the MDR through university seminars and supplementary training.
I am looking for a Working Student position or Internship in Munich where I can support a QM/RA team with documentation, process maintenance, and validation tasks.
Experience
Student Research Assistant (Hiwi)
Bavarian Cancer Research Center (BZKF)Sep 2023 — Feb 2025
Erlangen, Germany
- •Researched and evaluated privacy-compliant data collaboration methods (Federated Learning) across multiple clinical sites, ensuring strict adherence to compliance requirements.
- •Executed rigorous cleaning and validation of sensitive oncology datasets to ensure data integrity and accuracy for scientific analysis.
- •Co-authored a peer-reviewed publication on FHIR standards, contributing specifically to the technical documentation and visualization of software validation results.
Research and Development Assistant
Senobar Kasht Co.
Sep 2018 — Aug 2020
Isfahan, Iran
- •Supported R&D processes for an eco-friendly alternative to pesticides using beneficial insects for plant protection.
Education
Master of Science, Medical Engineering
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Oct 2022 — Expected Sep 2026
Erlangen, Germany
- •Specialization in Image and Data Processing
Bachelor of Engineering, Biomedical Engineering
AZAD University
Oct 2015 — Jan 2020
Isfahan, Iran
- •GPA: 1.6 (German Scale)
- •Medical Informatics, Electrical Engineering, Mathematics
Regulatory & QM Training
Certificate course: Medical Device Regulation (MDR)
FAU Erlangen NürnbergOct 2025 — Jun 2026
In Progress10-part seminar series covering the full product life cycle under EU MDR.
Focus: Software for Medical Devices, Risk Management (ISO 14971), and Clinical Evaluation.
Specialized training on IEC 62304 standard for Medical Device Software lifecycle processes.
Focus: SaMD regulatory requirements, ISO 14971 for software risk management, and FDA Design Controls.
Skills
Programming & Data
Machine Learning
Regulatory Knowledge
Languages
Interests & Career Goals
Contact
I'm currently looking for a Working Student position or Internship in Quality Management or Regulatory Affairs in Munich. Feel free to reach out!