Quality Expert & Regulatory Affairs Manager

• Senior Quality & Regulatory Affairs consultant with 20+ years of experience leading QMS, remediation, and lifecycle/change management in medical devices and automotive, ensuring compliant, audit-ready processes

• Extensive hands-on expertise across ISO 13485, ISO 14971, MDR (EU 2017/745), FDA/21 CFR 820 and IEC standards, delivering technical documentation, verification/validation, and design transfer to suppliers

• Proven track record managing NCs, CAPAs, supplier management and internal/supplier audits, supporting global organizations with measurable quality improvements

• Strong project leadership expertise, coordinating crossfunctional teams, resources and milestones while maintaining robust documentation control and postmarket surveillance readines

• Coordinates and oversees lifecycle-management activities

• Project resource and action planning within lifecycle management

• Maintains ticket overview, bundles, evaluates and coordinates tasks

• Facilitates interdisciplinary meetings and documentation updates in change management

• Consulting services in medical technology, focusing on quality and regulatory affairs

• Reviewed QMS documents for ISO 13485 compliance and created new quality-management documents

• Handled non-conformities (NCs) and corrective-preventive actions (CAPAs)

• Supplier management and execution of internal & supplier audits

• Risk management consulting for a product family

• Reviewed and updated the risk file

• Developed a statistically-based sampling concept for product release testing

• Provided consulting and support for technical documentation and quality management

• Handled non-conformities and CAPAs

• Supported technical documentation creation and review

• Quality-management consulting for ophthalmic research products

• Reviewed QMS documents for ISO 13485 and MDSAP compliance

• Interim role covering a broad range of quality-management activities

• Preparation for audits and support of interim QM manager

• Technical documentation handling, NC and CAPA processing

• Supplier management

• Technical consulting for product labeling and documentation updates

• Advised R&D transition for all products

• Independently updated device and packaging labels and user manuals

• Managed SAP To-Do items based on labeling changes

• Supported SNAP process with suppliers for self-procured products

• Developed and maintained the quality-management system (QMS) according to EN ISO 13485

• Coordinated all processes of a medical-device manufacturer within the QMS

• Created, updated, and monitored technical documentation and conformity declarations

• Product surveillance after market release

• Performed KPI analysis, customer complaint handling, procedure and work-instruction approval

• Delivered internal QMS trainings and supported management review

• Supported document-control processes and regulatory affairs

• Assisted in redesigning the document-control process

• Provided regulatory-affairs support for risk-management and creation of two new technical product files

• Advised on transition from MDD to MDR for Class IIa and IIb products

• Helped migrate the QM system from paper to electronic format with MDR compliance

• Handled complaints, CAPAs, SOP/FO creation, and participated in 13485 audits

• Led several remediation projects for heart-lung machines

• Performed GAP analyses, risk assessments, and risk management

• Managed design transfers to suppliers and manufacturing

• Handled component relocation activities

• Executed change-management processes according to the DMO2000 framework within lifecycle engineering

• Coordinated and implemented changes for active medical devices (e.g., heart-lung machines) internally and with suppliers

• Experience in the development, processing and quality handling of a broad range of components and devices for the automotive and medical technology sectors

• Medical technology sector: Heart-lung machines, Implantable intra-ocular lenses, COVID-19 diagnostic devices

Completed a comprehensive regulatory training program covering the European Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR):

• Module 1: Technical documentation for medical devices and in-vitro diagnostics

• Module 2A: General safety and performance requirements for active medical products, including medical software

• Module 2B: General safety and performance requirements for non-active medical products, including medical software

• Module 2C: General safety and performance requirements for in-vitro diagnostics

• Module 3: Requirements & processes for the development of medical devices & IVD

• Module 4: Risk management for medical devices and in-vitro diagnostics according to ISO 14971:2019

• Module ERVP: Responsibilities for ensuring compliance with regulatory requirements

• Module 5A: Clinical evaluation & testing of medical devices according to MDR

• Module 5B: Clinical evaluation & testing of IVDs according to IVDR

• Module 6: Labelling with UDI & labeling of medical devices and in-vitro diagnostics

• Module 7/1: Post-market surveillance, PMCF and PMS plans

• Module 7/2: Continued post-market surveillance activities