Project Manager | Life Science Consulting

Experienced Regulatory Affairs Manager specializing in clinical evaluations, technical documentation and compliance management. Successfully authored regulatory documents, and coordinated multinational projects.

• Biologie
• Clinical Evaluation
• Complaint Management
• DIN EN ISO 13485
• ISO 14971
• MDR
• Medical Writing5 J.
• PMCF
• PMS
• Projektmanagement5 J.
• Regulatory Affairs Manager5 J.

Regulatory Affairs and Clinical Affairs expert with over 10 years of experience in the life sciences industry, including 6 years in medical devices (Class I–III) and 4 years in regulatory documentation. Proven expertise in clinical evaluations, technical documentation, PMCF studies, and MDR submissions. Successfully led international, multicenter projects with a focus on regulatory compliance, stakeholder communication, and quality management. Trilingual: German, English, Russian. Represented companies at international trade fairs and scientific congresses.

• Technical Documentation (EU MDR 2017/745, MDD, IVDR)
• Clinical Evaluation & Investigation (MEDDEV 2.7/1 Rev. 4, ISO 14155)
• Medical Writing: CEP, CER, PMCF, CSRs
• Post-Market Surveillance & PMCF Strategy
• ISO 13485 Quality Management | ISO 14971 Risk Management
• CAPA & Complaint Management | Non-Conformance Validation (SAP)
• Project Management & Technical Account Support
• DiGA Authorization & Software Verification
• SOP Development & Change Management
• Multilingual Communication (German, English, Russian)
• Master of Science in Biology
• 10+ years of experience in Clinical Research, Regulatory Affairs, and Quality Management
• Authoring of CEPs, CERs, CSRs, Study Protocols, IBs, ICFs
• In-depth knowledge of MDR, IVDR, FDA CFR, ICH-GCP, ISO 13485, ISO 14971
• Leadership in PMCF studies and regulatory communication with authorities
• Experience with RFIs and Notified Body feedback
• SAP-based NC and CAPA processing
• Market analysis and product presentation at international trade fairs