M.Sc. Medical Engineering Student | RAPS Member
Hadieh Ghanbarian
Focus: Quality Management (QMS) & Regulatory Affairs
About
As a Master's student in Medical Engineering, I combine a deep technical understanding of AI and Medical Image Processing with a rigorous focus on Quality Management and Regulatory Affairs. I understand not just that a device must be compliant, but how the underlying software and data function.
To solidify this expertise, I am actively pursuing a university certificate in EU MDR 2017/745 and holding membership with RAPS. My goal is to ensure that cutting-edge medical software is safe, effective, and market-ready.
What I bring:
- •Technical Fluency: Python, Data Processing, and AI/ML lifecycles
- •Regulatory Knowledge: ISO 13485, ISO 14971, and IEC 62304
- •Practical Experience: Clinical data integrity and technical documentation
I am currently seeking a Working Student position or Internship in Munich to support QM/RA teams with technical documentation and compliance strategies.
Experience
Student Research Assistant
Bayerisches Zentrum für Krebsforschung (BZKF)Lighthouse AI & Bioinformatics
Sep 2023 — Feb 2025
Erlangen, Germany
- •Ensured Data Privacy & Compliance: Implemented secure data collaboration protocols strictly adhering to privacy standards (GDPR) for multi-site clinical studies.
- •Data Quality Control & Integrity: Performed rigorous data cleansing and verification of oncology datasets to ensure high-quality inputs for clinical evidence generation.
- •Technical Documentation: Co-authored technical analysis and validation visualizations for a peer-reviewed study on FHIR interoperability standards.
Research and Development Assistant
Senobar Kasht Co.
Sep 2018 — Aug 2020
Isfahan, Iran
- •Process Optimization: Supported the implementation of standardized workflows for the production of eco-friendly biological agents.
- •Quality Control: Monitored experimental protocols to ensure consistent product efficacy and adherence to environmental safety standards.
- •Documentation: Recorded process data and experimental results to support product development.
Education
Master of Science, Medical Engineering
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Oct 2022 — Expected Sep 2026
Erlangen, Germany
- •Specialization: Medical Image & Data Processing
- •Focus: Bridging technical software expertise with Regulatory Affairs and Quality Management
- •Key Coursework: Medical Imaging, AI, Machine Learning, SaMD lifecycles, Anatomy, Physiology, Clinical MR Protocols
Certificate, Medical Device Regulation (MDR) & Quality Management
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Oct 2025 — Jul 2026
Erlangen, Germany
- •Comprehensive university certificate program (10-part seminar series) covering the full product lifecycle under EU MDR 2017/745
- •Core Modules: EU MDR 2017/745, ISO 13485 (QMS), ISO 14971 (Risk Management), IEC 62304 (SaMD)
- •Additional Topics: AI in MedTech, IEC 62366 (Usability), Clinical Evaluation (CER), Post-Market Surveillance (PMS)
Bachelor of Engineering, Biomedical Engineering
Azad University (IAU)
Sep 2015 — Jan 2020
Isfahan, Iran
- •GPA: 1.6 (German Scale)
- •Focus: Medical Device Technology & Engineering Principles
- •Core Curriculum: Medical Electronics, Medical Instrumentation, Bioinformatics, Mathematics
- •Clinical Exposure: Hospital rotations with MRI, CT, Ultrasound device applications
Professional Memberships
Regulatory Affairs Professionals Society (RAPS)
Member
Dec 2025 — Present
Utilizing member resources to deepen understanding of EU MDR, ISO 13485, and global regulatory strategies.
Skills
Regulatory Standards
Technical Skills & Data
Documentation Tools
Languages
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!