Recommended expert
Desalegne (A.) Syit
Medical Device Auditor (ISO 13485, ISO 9001)
Experience
May 2025 - Present
10 monthsFrankfurt, 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 monthsWorms, 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 monthsFrankfurt, 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 monthsFrankfurt, 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.)
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Biotechnology (6.5 years), Education (5.5 years), and Healthcare (3.5 years).
Biotechnology
Education
Healthcare
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Research and Development (6.5 years), Quality Assurance (3.5 years), and Audit (1 year).
Research and Development
Quality Assurance
Audit
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
NativeEnglish
AdvancedEducation
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
Profile
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Frequently asked questions
Do you have questions? Here you can find further information.
Where is Desalegne based?
Desalegne is based in Schwalbach am Taunus, Germany.
What languages does Desalegne speak?
Desalegne speaks the following languages: German (Native), English (Advanced).
How many years of experience does Desalegne have?
Desalegne has at least 9 years of experience. During this time, Desalegne has worked in at least 4 different roles and for 4 different companies. The average length of individual experience is 2 years and 2 months. Note that Desalegne may not have shared all experience and actually has more experience.
What roles would Desalegne be best suited for?
Based on recent experience, Desalegne would be well-suited for roles such as: Medical Device Auditor (ISO 13485, ISO 9001), Regulatory Affairs & Quality Management Manager, Laboratory Manager & Quality Manager.
What is Desalegne's latest experience?
Desalegne's most recent position is Medical Device Auditor (ISO 13485, ISO 9001) at DQS Medizinprodukte GmbH.
What companies has Desalegne worked for in recent years?
In recent years, Desalegne has worked for DQS Medizinprodukte GmbH, Bio-gram diagnostics GmbH, HTS Labs Frankfurt and CoviMedical GmbH, and Goethe-University Frankfurt am Main.
Which industries is Desalegne most experienced in?
Desalegne is most experienced in industries like Biotechnology, Education, and Healthcare.
Which business areas is Desalegne most experienced in?
Desalegne is most experienced in business areas like Research and Development (R&D), Quality Assurance (QA), and Audit.
Which industries has Desalegne worked in recently?
Desalegne has recently worked in industries like Biotechnology, Education, and Healthcare.
Which business areas has Desalegne worked in recently?
Desalegne has recently worked in business areas like Research and Development (R&D), Quality Assurance (QA), and Audit.
What is Desalegne's education?
Desalegne holds a Doctorate in Biology from Goethe-University Frankfurt am Main and a Master in Tropical Veterinary Public Health from Addis Ababa University.
Does Desalegne have any certificates?
Desalegne has 1 certificate: IHK training "Exportpraxis kompakt".
What is the availability of Desalegne?
Desalegne is immediately available full-time for suitable projects.
What is the rate of Desalegne?
Desalegne's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.
How to hire Desalegne?
To hire Desalegne, click the Meet button on the profile to request a meeting and discuss your project needs.
Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
1200
900
600
300
Market avg: 850-1010 €
Market avg: 850-1010 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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