I am a senior consultant in medical device regulation with experience in the field of medical device regulations as well as pharmaceutical industry. After 5 years in method development and trouble shooting for QC and drug substance manufacturing at a pharmaceutical company, I worked at Notified Body KEMA Quality / DEKRA for 2.5 years. As a project manager I performed quality system audits and dossier reviews under EU Medical Device regulations. I served clients ranging from small startup companies in technology hotspots like Israel to large multi-site high risk device manufacturers. In addition, I was trained as biological safety reviewer for high risk medical devices. Furthermore, I was involved in several projects for which consultation at national health authorities was required for the drug substance part of drug-device combinations.
After working at DEKRA, I was employed for 3 years at a pharmaceutical company as a team lead of the customer and regulatory support services team: this involved responding to deficiency letters of Health Authorities, customer complaints and providing regulatory support to drug product manufacturers (DMF, ASMF, CEP dossiers).
I can fulfill various functions, like e.g. QA/RA manager, Project manager/Expert member in D&D projects for the above mentioned areas of expertise and internal or supplier auditor.
My fields of expertise are in:
– Set up/write/maintain technical dossiers
– Biological safety evaluations
– Analytical (bio)chemistry (e.g. HPLC, ELISA, PCR, kinetic test methods, protein content)
– Set up quality management systems (ISO 13485 / ISO 9001)
– Internal/supplier auditing
– Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
– High risk non active medical devices: cardiovascular / orthopedic / wound dressings, including drug-device combinations and devices with animal tissue (derivatives)
– Equipment qualifications and validations (e.g. production, packaging, shelf-life)/p>