Desalegne S.
PhD in Biology | DVM, MSc | Quality Management & Regulatory Affairs Expert | Auditor for Medical Devices (ISO 13485, ISO 9001)
Experience
Medical Devices Auditor (ISO 13485, ISO 9001)
DQS Medizinprodukte GmbH
- Conducting external audits in medtech with a focus on GMP, MDR, and QMS compliance.
- Evaluating CAPA measures, validation documentation, and regulatory study documents.
- Training teams in audit readiness and quality awareness.
Regulatory Affairs & Quality Management Manager
Bio-gram diagnostics GmbH
- Developing and maintaining technical documentation according to 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.
- Participating in an IHK training 'Export Practice Compact' (INCOTERMS® 2020, export handling, letter of credit, cost calculation).
Laboratory Manager & Quality Manager
HTS Labs Frankfurt and CoviMedical GmbH
- Leading and overseeing in-house lab processes according to GMP/ISO 15189.
- Planning and conducting internal audits, deviation analyses, and corrective actions.
- Creating and maintaining SOPs and study protocols for diagnostic tests.
Research Scientist in Molecular Biology
Goethe-University Frankfurt am Main
- Planning and executing 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
Results-oriented scientist, veterinarian, and quality manager (Ph.D. in Biology, DVM, M.Sc.) with over eight years of experience in research, clinical trial management, quality management, and regulatory processes in the pharmaceutical and diagnostic sectors.
Comprehensive expertise in planning, executing, and evaluating preclinical and clinical studies under GLP/GCP-compliant conditions, preparing documentation for approval procedures (MDR, GMP, VICH), and conducting audits and risk management.
Skilled in working with authorities, CROs, universities, and interdisciplinary teams worldwide.
Excellent communication skills in German and English, with strong intercultural competence and team leadership experience.
Languages
Education
Goethe-University Frankfurt am Main
Ph.D. · Biology · Frankfurt, Germany
Addis Ababa University
Master of Science · Tropical Veterinary Public Health · Addis Ababa, Ethiopia
Addis Ababa University
Degree of Veterinary Medicine · Veterinary Medicine · Addis Ababa, Ethiopia
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