14.10.2026 aktualisiert
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Technical and Regulatory Consultant | Medical Devices & Drug-Eluting Technologies
Berlin, Deutschland
Weltweit
Doctoral Degree (Dr.-Ing.), Technical University of Munich, summa cum laudeÜber mich
Expert in DCB technology, deep technical and regulatory know-how based on many years of experience. Extensive knowledge of PTCA/ PTA catheters and ultra-high-pressure balloons. I offer guidance on development of new combination products, optimization projects and support with CE MDR certification.
Skills
MedizintechnikDesign und TechnologieRegulatorische EntwicklungenRegulatory Affairs
R&D Management & Product Development
Extensive experience in leading international R&D groups, developing new medical device products such as drug-eluting balloons and stents, and overseeing technical supervision of certification processes including MDR certifications.
Regulatory Affairs & Certification
Deep expertise in regulatory processes for medical devices, including technical supervision of MDR certifications, preparation of FDA submissions, and creation of design dossiers for international markets such as Japan.
Coating Technology & Drug-Eluting Systems
Specialized knowledge in coating process development for medical devices, including development of coating technology for coronary stents and drug-eluting balloons.
Biocompatibility Assessment
Expert-level competence in biocompatibility assessment of medical devices acc. to ISO 10993.
Statistical Data Analysis
Advanced skills in statistical data analysis for experimental and process data evaluation.
Scanning Electron Microscopy (SEM/EDX)
Expert-level proficiency in scanning electron microscopy including EDX analysis for material and surface characterization.
Material Failure Analysis
Advanced skills in material failure analysis applied to medical engineering and implant contexts.
Surface Microstructuring
Research and practical expertise in surface microstructuring of metals, including electrochemical etching techniques for controlled drug release applications.
Project Management
Proven track record in managing complex medical engineering projects across multiple organizations, including international coordination and cross-functional team leadership. Proficient in design of experiments and process validation.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2025
Sprachen
DeutschMutterspracheEnglischverhandlungssicherSpanischgut
Projekthistorie
Working as an independent technical and regulatory consultant in the medical device field.
Coordination of international R&D groups. Development of new products and technical supervision of certification processes (drug-eluting balloons and drug-eluting stents amongst others). Technical supervision of MDR certifications.
Development of a drug-coated PTA catheter portfolio, creation of design dossier for submission in Japan.