À propos de Jurij
Short version: Experienced Quality Engineer and Regulatory Expert. Support you hands on Technical Documentation, ISO test required, Process and Test Method Validations, Project Management and Design and Manufacturing Transfers, as well as conducting internal and supplier audits efficiently based on your needs. Actually everything around your medical device.
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Ready to support with Quality Management System implementation acc. to EN IS013485:2016, EU MDR 2017/745; MDSAP, FDA CFR 21 part 820. Can audit your organization or supplier for compliance and product qualtiy. And just support where you need a second opinion or a suggestion to regulatory strategy, issues occured and concern to be eliminated.
Proven experience to set up a Quality Management System from scratch, but also to maintain and adopt QMS as needed in larger organisations in different departments like PMS, Clinical Afairs, Quality, Regulatory etc.
Highly committed Quality & Compliance expert with extensive track record in a regulated environment since 2010. Passionate about Quality Management with organizational and people leadership experience covering Quality Operations & Manufacturing, Strategic Quality & Regulatory Planning, Continuous Improvement, Supplier Quality, Customer Quality, Audit Management and EU-MDR/FDA/GMP/ISO/MDSAP regulatory expertise.
My career showcases my ability to lead global teams and projects effectively, leveraging exceptional communication, analytical, and problem-solving skills. As a recognized QMS expert, I have successfully managed quality and regulatory projects, from establishing new design and manufacturing sites to overseeing technology transfers and securing regulatory approvals across various regions incl. but not to limited to EU, UK, USA,...
my projects have been conductucted/executed in: Switzerland, Germany, UK, USA, France, China.
Allemand
Bilingue ou natif
Russe
Capacité professionnelle complète
Anglais
Capacité professionnelle complète
Accepte de travailler sur site
Solothurn (jusqu’à 50 km), Zürich (jusqu’à 50 km), Basel (jusqu’à 50 km)
Expériences
- Genostis AGHead of Quality and Regulatory Affairs & Labeling/Packaging DepartmentINDUSTRIE PHARMACEUTIQUEoctobre 2024 - Aujourd'hui (1 an et 8 mois)Derendingen SO, Suisse
- Leadership and oversight of the QM/RA and Packaging/Labeling departments incl. Clean Room for legal manufacturer and contract manufacturer roles for up to 8 employees
- Responsible for QM, RA, PMS, Clinical Affairs, Risk Management, Validation, Audits
- Continuously review and update quality management system in compliance with EN ISO 13485, MDR, FDA 820, GMP and other rel. standards for sterile and non-sterile products
- Verification of medical device conformity, maintenance of technical documentation, market surveillance, risk management and regulatory reporting
- Facilitating the effectiveness and sustainability of the QMS while managing authorities and certification audits
- Execution of operational objectives, including deadlines, quality benchmarks, and costefficiency targets to meet regulatory and business needs
- Overseeing IPC tensile strength and PEEL testings, including sealing verification and tool inspections. Coordinating water monitoring for purified and process water systems
- Supervised air particle monitoring in ISO Class 7 and 8 cleanrooms, airlocks, and other controlled environments to maintain environmental control standards
- Review and approve all regulatory responses incl. vigilance, change management, submissions etc. in timely manner
- Compliance assessments internally and by supplier as Lead Auditor
=> Achievement: moved from one CE-certified device to four full product groups (>400 devices) and obtained key international approvals (EU MDR, UK MDR, FDA 510(k) for implants). In parallel QMS was completely restructured and made fit for MDSAP certification. - Hamilton Medical / EU MDRProject Manager and Quality ConsultantSECTEUR MÉDICALjanvier 2019 - octobre 2024 (5 ans et 9 mois)Domat/Ems, Suisse• Project Manager responsible for leading and coordinating of activities related to Medical Device Regulation (EU MDR) across different locations (CH/USA/GER/ROU/...), incl.:• project controlling and coordination of the ventilation devices and consumables• conducting project management activities such as GAP Analysis, planning and updating timelines, report status, defining work packages and setting up priorities• leading, collaboration and work hands-on with different stakeholders e.g., regulatory, quality, engineering, manufacturing, suppliers, business partners and notified bodies• review, planning and updating tasks for technical documentation, classification, PMS (including clinical Evaluation, PSUR, etc.), risk management, economical operators, EUDAMED, unique device identification (UDI), outsourced processes• updating and implementing new processes as required due to changed regulatory environment (e.g. introducing MIR form, reporting in UK in MORE database etc., registering economical operators and devices in EUDAMED and swissmedic)=> Achievement: EU-MDR certification for product portfolio of Hamilton Medical AG and medin Medical Innovations GmbH• Lead strategy and certification process for EN ISO 13485 at new established manufacturing facility in US. => Achievement: EN ISO 13485 certificate for Hamilton Medical Inc.• Project Leader for Compliance related to Brexit and UK MDR. Project in progress• QA/RA project member in three (3) development projects• Compliance Expert for Technology Transfers and Global Quality Alignment topics
- YPSOMEDConsultant – Interim Quality ManagerINDUSTRIE PHARMACEUTIQUEjuillet 2018 - décembre 2018 (5 mois)Burgdorf, Suisse• Planning and handling the overall activities for assuring quality and compliance within Diabetes Care Business Unit (Insulin Pump System: Hardware, Software (embedded+app), Touchscreen, delivery system; Infusion sets; Needles)• Review and Release of Qualification and Validation documents concerning cleanroom, test methods, risk files; QA Lean-Project member to increase production line capacity• Products/ Batch release of finished goods and subassemblies• Product Care and PMS Team member for Diabetes Pump. Support for new established site in Germany. Subject Matter Expert for qualification and validation activities• MDSAP Audit support and SME for CAPA and Change Management
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Formations
- Clinical-Medical TechnologyRheinische Friedrich-Wilhelm Universität Bonn (M.Sc)2017Clinical-Medical Technology
- Bio-Medical Engineering (Bio-Medizintechnik)Hochschule Furtwangen University2014Bio-Medical Engineering (Bio-Medizintechnik)
Certifications
- Internal Auditing to the Medical Device Single Audit Programm Including ISO 13485:2016 and Device Regulations from MDSAP JurisdictionsOriel STAT A MATRIX2023
- Product Certification: CE and UKCA MarkingBSI Training Academy2022
Compétences
Catégories
- Autre