Hadieh Ghanbarian

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

Federated LearningData ValidationPythonFHIR

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.
R&DProcess Implementation

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
First rank in biomedical summerschool 2019, Isfahan

Regulatory & QM Training

Certificate course: Medical Device Regulation (MDR)

FAU Erlangen Nürnberg

Oct 2025 — Jun 2026

In Progress

10-part seminar series covering the full product life cycle under EU MDR.

Focus: Software for Medical Devices, Risk Management (ISO 14971), and Clinical Evaluation.

Medical Device Software Process Blackbelt (IEC 62304)

Udemy

Nov 2025

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.

Medical Device Process Validation (ISO 13485)

Udemy

Sep 2025

Technical training on ISO 13485 process validation.

Focus: IQ, OQ, PQ protocols and required documentation.

Skills

Programming & Data

PythonpandasNumPyscikit-learnmatplotlibJupyterGit

Machine Learning

Model EvaluationCross-validationFederated LearningFlower Framework

Regulatory Knowledge

ISO 13485IEC 62304ISO 14971EU MDRFDA Design Controls

Languages

English (C1)German (B1)Persian (Native)

Interests & Career Goals

Quality Management for Medical SoftwareMedical Device Regulation (MDR)Process DocumentationAI in Healthcare

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!