Desalegne (A.) S.

Medical Device Auditor (ISO 13485, ISO 9001)

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Schwalbach am Taunus, Germany

Experience

May 2025 - Present
8 months
Frankfurt, Germany

Medical Device Auditor (ISO 13485, ISO 9001)

DQS Medizinprodukte GmbH

  • Conducting external audits in medical technology with a focus on GMP, MDR and QMS compliance
  • Assessing CAPA actions, validation documents and regulatory study materials
  • Training teams in audit readiness and quality awareness
Mar 2024 - May 2025
1 year 3 months
Worms, Germany

Regulatory Affairs & Quality Management Manager

Bio-gram diagnostics GmbH

  • Developing and maintaining technical documentation under the MDR (Annex II & III) for diagnostics
  • Evaluating clinical data and performance studies, supporting approval processes
  • Collaborating with labs, R&D and external authorities to ensure regulatory requirements
  • Participated in IHK training "Exportpraxis kompakt" (INCOTERMS® 2020, export procedures, letters of credit, costing)
Dec 2021 - Apr 2023
1 year 5 months
Frankfurt, Germany

Laboratory Manager & Quality Manager

HTS Labs Frankfurt and CoviMedical GmbH

  • Leading and overseeing in-house lab processes according to GMP/ISO 15189
  • Planning and executing internal audits, deviation analyses and corrective actions
  • Creating and maintaining SOPs and study protocols for diagnostic tests
May 2016 - Sep 2021
5 years 5 months
Frankfurt, Germany

Molecular Biology Research Scientist

Goethe-University Frankfurt am Main

  • Planning and conducting preclinical research projects in drug development (antimicrobial peptides)
  • Developing new methods and animal models to assess biological efficacy
  • Supervising students and collaborating with interdisciplinary research teams
  • Publications in international peer-reviewed journals (e.g. Nature Chemistry, J. Agric. Food Chem.)

Summary

Result-oriented scientist, veterinarian and quality manager (Ph.D. in Biology, DVM, M.Sc.) with over eight years of experience in research, clinical study management, quality management and regulatory processes in the pharmaceutical and diagnostic field.

Extensive expertise in planning, conducting and evaluating preclinical and clinical studies under GLP/GCP-compliant conditions, documentation for approval processes (MDR, GMP, VICH), as well as audit and risk management. Experienced in collaborating with authorities, CROs, universities and interdisciplinary teams worldwide.

Skills

  • Planning, Conducting & Analyzing Clinical And Preclinical Studies (Gcp/glp/vich)
  • Veterinary Research: Animal Models, Antiparasitics, Therapeutics
  • Regulatory Requirements: Gmp, Mdr, Iso 13485, Iso 9001
  • Study Management: Study Protocols, Animal Use Applications, Data Analysis, Report Writing
  • Audit & Capa Management, Deviation Assessment, Risk Management
  • Collaboration With Authorities, Cros, Universities
  • Communication & Leadership: Cross-functional Teams, Training, Scientific Presentation

Languages

German
Native
English
Advanced

Education

May 2016 - Sep 2021

Goethe-University Frankfurt am Main

Ph.D. in Biology · Biology · Frankfurt, Germany

Sep 2006 - Jul 2008

Addis Ababa University

Master of Science, Tropical Veterinary Public Health · Tropical Veterinary Public Health · Addis Ababa, Ethiopia

Sep 1999 - Jul 2005

Addis Ababa University

Degree of Veterinary Medicine · Veterinary Medicine · Addis Ababa, Ethiopia

Certifications & licenses

IHK training "Exportpraxis kompakt"

IHK

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