Experience

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  Roche

  Apr 2015 - Jan 2025

  Pre-Market Quality - Quality & Regulatory.Business Area: Molecular Diagnostics with focus on Systems, Instruments & Consumables.Mission: Successfully led and managed the design and development delivery for multiple products within the Molecular portfolio, encompassing significant software updates, new consumables development, and the creation of new instrument development activities. Provided support across the spectrum from Research Use Only (RUO) to In Vitro Diagnostics Regulation (IVDR) products.Additionally, played a pivotal role in implementing a new Quality Management System to align with industry standards such as ISO13485, ISO9001, and more. This included the review and enhancement of Global Standardized Processes, Network Procedures, and Deliverables lists to ensure compliance and operational excellence.Subject Matter Expertise: IVDR 2017/746, MDR 2017/745, ISO 13485, ISO 14971, IEC 62366, IEC 62304 (SaMD), ISO 9001, FDA 21 CFR 820, Design Control & Change Management, GMP / GDP. Show less Global Operations Consumables - Global OperationsBusiness Area: Molecular Diagnostics with focus on Raw Materials V&V and Q&V projects.Mission: Successfully led an EoL (End-Of-Life) raw material (RM) project, identifying a new RM to mitigate a critical delivery issue caused by end-of-life materials. This initiative ensured timely replacement of raw materials for several products affected by supply chain disruptions. Project leadership included stakeholder management, particularly with Injection Molding & Medical Plastics CMOs, while overseeing Qualification & Validation from production lines activities and Verification & Validation activities for the final product. Provided end-to-end support from Raw Material Assessment to Saleable Product, ensuring seamless continuity in production.Additional support was provided in Change Management & Technical Documentation Management in alignment with QMS standards.Subject Matter Expertise: Qualification & Validation, Verification & Validation, Medical Grade Plastics, CMOs Management, Project Leadership, Change Control Show less System Integration - Research & DevelopmentBusiness Area: Immunology Assays within the CoreLab portfolio.Mission: Played a pivotal role in supporting reagent validation for a cross-functional projectwith Suzhou, China while fostering close collaboration with the team in Penzberg, Germany. Conducted extensive laboratory measurements and testing to ensure the accuracy and reliability of the reagents. Additionally, supported the preparation of submission documentation in compliance with local regulations and guidelines in China.Subject Matter Expertise: Reagent Validation, Laboratory Measurements, Submission Documentation, Compliance with Local Regulations, Cross-Team Collaboration. Show less System Integration - Research & DevelopmentBusiness Area: Clinical Chemistry within the CoreLab portfolio.Mission: Contributed significantly to the support of reagent validation for a cross-functional project with Suzhou, China while fostering close collaboration with the team in Penzberg. Conducted extensive laboratory measurements and testing to ensure the accuracy and reliability of the reagents, and provided vital support for the preparation of submission documentation in compliance with local regulations and guidelines in China.Subject Matter Expertise: Reagent Validation, Laboratory Measurements, Submission Documentation, Compliance with Local Regulations, Cross-Team Collaboration. Show less Business Area: System Integration - Coagulation Systems - Verification & Validation / ReliabilityMission: Played a pivotal role in the verification and validation campaigns, both pre and post-launch, encompassing comprehensive testing of hardware, software, and consumables for the coagulation instruments. Conducted rigorous testing to ensure the reliability and performance of the instruments, analyzing various system aspects and collaborating with cross-functional teams to address any identified issues effectively.Subject Matter Expertise: Verification and Validation Campaigns, Comprehensive Testing, Analysis of Test Results, Collaboration with Cross-Functional Teams, Continuous Improvement, System Reliability. Show less

  • Design Quality Assurance Manager

    Nov 2022 - Jan 2025

  • Project Lead Global Operations Consumables

    Apr 2021 - Nov 2022

  • Development Engineer Applications

    Jun 2019 - Apr 2021

  • Application Specialist

    Feb 2018 - May 2019

  • Test Analyst

    Apr 2015 - Jan 2018
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  Qunique gmbh

  Jan 2025 - now

  Senior consultant quality managament & regulatory affairs

  Specialized in Medical Devices, Diagnostics & Pharmaceuticals with a focus on achieving compliance and maintaining high-quality standards for clients.Mission: Established and optimized Quality Management Systems (QMS) from inception to regular revisions, incorporating latest regulatory updates.Ensured quality integration throughout the Design and Development (D&D) process to robust Supplier Management processes.Provided tailored training programs on GxPs, IVDR, FDA regulations, CAPA improvements, Operations optimization, and emerging regulatory requirements.Guided clients through the complex and evolving regulatory landscape to maintain the highest standards of quality and compliance.Subject Matter Expertise:- EU Regulations: IVDR 2017/746, MDR 2017/745- Quality Standards: ISO 13485, ISO 9001- Risk Management: ISO 14971- Usability Engineering: IEC 62366- Software as a Medical Device (SaMD): IEC 62304- US Regulations: FDA 21 CFR 820, QMSR- Design Control & Change Management- Good Manufacturing and Distribution Practices (GMP/GDP)- Post-market surveillance requirements (including 2025 GB regulations)- Pre-market regulations including international recognition frameworks- Electronic Instructions for Use (eIFUs) for all medical devices- AI and software regulations in medical devices- Cybersecurity requirements for SaMD- International reliance schemes for market access Show less