I am a senior consultant in the medical device and biotechnology regulation and standardization area, working for start-ups as well as multinationals, fulfilling various functions, like e.g. QA/RA manager, Project manager/Expert member in D&D projects, Validation engineer, Auditor, Facility manager, technical writer.
I worked as a project leader in a pharmaceutical company and was involved in setting up a new laboratory facility with responsibility for building and equipment installation and validation. I also worked as facility manager and project manager in a tissue engineering company. Before that I worked as a study director in a biological safety testing facility. I started in a university hospital working on biomaterials and tissue interactions, using histological and electron microscopical evaluation techniques.
My fields of expertise are in:
Project management design and development of medical devices
Building, utility & clean room validations
Laboratory & clean room installations
Facility management focused on medical device/pharma related companies
Equipment qualifications and validations (e.g. production, packaging, shelf-life)
Set up/write/maintain design history files, technical dossiers, 510(k) dossiers and Master Files
Set up quality management systems (ISO 13485 / ISO 9001)
Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
Histology/cytology and Electron microscopy (TEM/ESEM)
A detailed curriculum vitae will be provided upon request