Regulatory, Quality & Analytics Consultant in the Medical Device Industry

Seeking to drive digital transformation within MedTech. #DataDrivenStrategy

• Auditor
• Data Science
• DIN EN ISO 13485
• EN ISO 14971
• International registrations
• IVDR
• MDR
• PRRC
• QMB
• Risikomanagement

Strong background in medical devices in Regulatory Affairs and Quality Management.
Worked several years as head of QM/RA, PRRC (MDR) and QM Rep. (EN ISO 13485).
Lead auditor in internal as well as supplier audits.
Deep knowledge ofrisk management andmedical device product life cycles.
Support in R&D projects to formulate a sound regulatory strategy.
Specializes in process optimization and automation leveraging methods like Lean Six Sigma and machine learning.
Responsible for raising awareness and training