Design Responsible in der In-Vitro Diagnostik

4+ years at a leading company for automated IVD. regulation-ready products from early design to PMS. QM following ISO13485, part. CM, RM, CAPA, and NC handling; IVDR Tecdoc and FDA pre-subs; Guideline implementation in V&V

• Change Management
• DIN EN ISO 13485
• Molekularbiologe
• Risikoanalyse
• Technische Dokumentation
• Wissenschaftler Regulatory Affairs

Design Responsible / Product Owner with 4+ years at a leading company for allergy and autoimmune diagnostics. I have contributed to high-quality, regulation-ready IVD products from early design phases to upscale, launch, and post-market surveillance. I bring together deep expertise in ISO 13485, IVDR, regulatory guidelines, and quality management, particularly risk, change, CAPA and complaint handling from an SME's perspective. Scientifically, I come with strong data skills in R, proteomics, and scientific visualization and a track record of translating this into concise words. I’m energized by teams that value collaboration, openness, and a genuinely positive work atmosphere.