Quality & Regulatory expert
Since 2021, Olena has been working as a Consultant for the Qserve Group. As part of the Quality and Regulatory Affairs team, Olena works with various low/high-risk devices under the EU MDR.
Before joining Qserve, she worked in the Quality Assurance department at a biotechnical company in Taiwan, gaining valuable experience with Class III devices under EU medical device (MDD/MDR) regulation and across various other international emerging markets. She was also responsible for global market registration and completed several registration projects in Asia and Eastern Europe. Olena started her career as a Quality Auditor at the Ukrainian Conformity Assessment Body and performed over 100 overseas quality management system audits. Olena holds degrees in Physics of Functional Materials from Taras Shevchenko National University of Kyiv (MSc). She also obtained a secondary degree – Bachelor of Arts in Theology, Ministry, and Mission with her MSc. Olena holds Lean Six Sigma Yellow Belt: Quantitative Tools for Quality and Productivity issued by Technische Universität München. She is of Ukrainian nationality and is fluent in Russian, Ukrainian and English.
The key expertise areas of Olena:
- Quality (System) Management. (interim) QA/RA management roles. Creating, implementing, maintaining, and improving Quality Management Systems in compliance with ISO 13485 standards, Medical Device Directive 93/42/EEC, EU MDR 2017/745 and FDA 21 CFR Part 820 (QSR) regulations.
- Auditing. Preparing and performing internal and supplier ISO 13485 quality system audits as certified Lead Auditor.
- Extended experience in preparing and participating as auditee in audits from Notified Bodies and external audits by various international regulatory authorities, resolving potential regulatory issues and negotiating submission issues with agency personnel.
- CAPA Management. Deploying, managing, and improving Corrective and Preventive Action processes & tools.
- Hands-on experience implementing the provisions of the Medical Device Directive (MDD, 93/42/EEC) and Medical Device Regulation (MDR) in authoring medical device regulatory submissions, planning and execution of regulatory strategy for obtaining CE Mark. This includes specific activities such as: Technical File set up and review for Class III medical devices with and without medicinal substance, borderline products, report writing, gap analyses and remediation for MDR, post-market surveillance system implementation, project coordination and support.
- Experience with reviewing advertising, labeling, promotional items for compliance to MDD/MDR.
- Experience with reviewing clinical evaluation reports to MEDDEV 2.7/1 Rev. 4 and MDR.
- Broad emerging market experience in submitting high risk product dossiers, as well as managing post-market support and registrations, in markets such as: Eastern Europe (Russia, Ukraine), Asia (India, Indonesia, Malaysia, Kazakhstan). This includes specific activities such as: document legalization processes, authentication/apostille, license amendments and Adverse Event reporting.