07.05.2026 aktualisiert

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80 % teilweise verfügbar

CEO & Management Consultant - Medical Device Industry

Rieden, Deutschland
Weltweit
Bachelor of Science in Biomedical Engineering
Rieden, Deutschland
Weltweit
Bachelor of Science in Biomedical Engineering

Profilanlagen

MC_SOQ_01_v06.pdf

Über mich

Geschäftsführer und Medizintechnikingenieur. Experte in den Bereichen Risikomanagement, Qualitätsmanagement, Projektmanagement sowie Regulatory Affairs für Medizinprodukte (überwiegend Klasse III). Internationale Erfahrung in der Durchführung und Leitung diverser regulatorischer Projekte.

Skills

Compliance
Regulatory Compliance Management
Comprehensive expertise in international project and program management for regulatory compliance including MDR, ISO 13485, and risk management according to ISO 14971

Quality Management Systems
Advanced knowledge in quality management and assurance implementation according to ISO 13485 with focus on medical device manufacturers

Medical Device Software Development
Specialized experience in software specification, verification, and validation according to IEC 62304 for class II-a medical devices

Risk Management and Usability Engineering
Extensive experience in risk evaluation according to ISO 22442 standards and usability engineering according to EN 62366-1

Technical Documentation Management
Creation and maintenance of compliant technical documentation and digitalization of quality management systems

Post-Market Surveillance
Implementation of post-market surveillance systems for combination products according to ISO 14971 and MDR 2017/745

Biocompatibility Evaluation
Biocompatibility evaluation according to ISO 10993 for infusion systems and combination products

Essential Performance and Basic Safety
General requirements for basic safety and essential performance according to IEC 60601 standards

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2020

Sprachen

DeutschMutterspracheEnglischverhandlungssicherPolnischgut

Projekthistorie

CEO & Management Consultant

MEDITEC Consulting GmbH

Pharma und Medizintechnik

< 10 Mitarbeiter

  1. Full Quality Management System implementation and certification for Class III medical device manufacturer of artificial heart valves. Regulatory and quality support for medical device manufacturers of endovascular and cardiovascular devices in terms of Post-Market Management according to MDR 2017/745.
  2. Regulatory and quality support for medical device manufacturers of endovascular and cardiovascular devices in terms of Post-Market Management according to MDR 2017/745 (EU)
  3. Risk Management & Usability Engineering process implementation for following device types (DE):
  4. Artificial Heart Valves incl. material from animal origin (e.g. Pericardium) incl. ISO 22442-1, -2, -3
  5. Endovascular Devices incl. material from animal origin (e.g. Collagen) incl. ISO 22442-1, -2, -3
  6. Implementation of Post Market Surveillance System for combination products according to ISO 14971 and MDR 2017/745 (SW, CH)
  7. Project lead for Risk Management of endoscopic devices – Implementation of a global process (US & EU) according to ISO 14971 including digitizing the process (Polarion)
  8. Project lead for Global Design Control / Production Control Processes (EU, CH, TW, US) Implementation for electromechanical drug-delivery devices according to ISO 13485 and other applicable standards including digitalization into the PLM environment (Teamcenter)

Senior Consultant - Regulatory Affairs & Project Management

NSF Prosystem GmbH

Pharma und Medizintechnik

10-50 Mitarbeiter

  1. Key Consultant for MDR 2017/745 implementation projects at class III manufacturers
  2. International Regulatory Affairs Management (European Economic Area, USA, Canada)
  3. Software Life-cycle Management documentation and process implementation according to EN 62304
  4. Usability Engineering process implementation and documentation according to EN 62366 / EN 62366-1 and FDA Guidance for Human Factors Engineering
  5. General requirements for basic safety and essential performance according to IEC 60601-1 3rd edition
  6. Project Management for MDD Technical File Remediation
  7. Risk Management according to ISO 14971 - incl. Design-FMEA and Process-FMEA acc. to IEC 60812 and Use-FMEA acc. to EN 62366-1
  8. Risk Management & Usability Engineering experience for following device types:
  9. Endovascular devices incl. material from animal origin (e.g. Heparin) incl. ISO 22442-1, -2, -3
  10. Robotic assistant surgery devices
  11. Combination products & Electromechanical drug-delivery devices
  12. Infusion systems & Infusion pumps
  13. Cardiovascular Devices incl. material from animal origin (e.g. Heparin)
  14. Dialyzer devices
  15. Orthopedic implants (active & non-active) incl. material from animal origin (e.g. Gelatin)
  16. Dental implants incl. material from animal origin (e.g. Gelatin)
  17. Orthopedic surgical instruments
  18. Stand-alone Medical Device Software
  19. Breast pumps and accessories
  20. Biocompatibility evaluation according to ISO 10993 for following device types:
  21. Infusion system and equipment
  22. Combination product

Consultant - Regulatory Affairs & Project Management

Prosystem AG

Pharma und Medizintechnik

10-50 Mitarbeiter

  1. Medical Device Registration in EU and USA (510k)
  2. Quality Management System optimization for infusion system manufacturer
  3. Risk Management according to ISO 14971 for infusion pumps
  4. Risk Management according to ISO 14971 for differenty types of implants and instruments (orthopedic, dental)

Medical Software Engineer

Prosystem Software GmbH

Pharma und Medizintechnik

10-50 Mitarbeiter

  1. Software specification and verification according to IEC 62304 for different class I and class II-a medical devices.
  2. Software tool validation according to ISO 13485 and GMP.
  3. Risk management file creation projects for class I and class II-a medical devices.

Design Verification Assisstant

QUALIMED Innovative Medizinprodukte GmbH

Pharma und Medizintechnik

50-250 Mitarbeiter

  1. Technical assistant in medical device manufacturer for cardiovascular devices (heparin coated stents)
  2. Construction of test apparatus for device verification.

Project & Research Associate

Hamburg University of Applied Sciences

Energie, Wasser und Umwelt

250-500 Mitarbeiter

Reserach and development of water cleaning system for airplanes with physical cavity method.

Medical Assistant

Cardiologicum Hamburg

Pharma und Medizintechnik

50-250 Mitarbeiter

  1. Medical assistant cardiac catheterization laboratory.
  2. Patient preparation and post-implantation patient care.

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