Creation and updates of Design History Files according to legal and regulatory requirements
Implementation of lifecycle management for medical products
Support in coordination and planning of the regulatory part of clinical evaluations, PMCF, and studies
Preparation of dossiers for FDA 510(k) clearances
Establishment of a risk management system according to ISO 14971
Redefinition and integration of requirements into existing processes
Development of a global regulatory affairs management system for the entire KLS Martin Group
Jan 2009 - Jun 2009
6 months
Starnberg, Germany
Quality Manager and Regulatory Affairs
StarMedTec GmbH
Laser lithotripters
Product approval according to legal and regulatory requirements of the EU, USA and Asia (focus: 93/42/EEC, MDD – 21 CFR 820 FDA GMP)
Implementation, execution, and maintenance of a QMS according to MDD requirements, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordination and execution of CAPA actions
Facilitation of cross-functional quality-related process alignments
Support of development projects
Apr 2008 - Dec 2009
9 months
Feldkirchen, Germany
Quality Manager
Pulsion Medical Systems AG
Cardio-circulatory systems in critical care
Implementation, execution, and maintenance of a QMS according to 93/42/EEC (MDD), FDA GMP (21 CFR 820), ISO 13485
Monitoring the application of quality tools and related tests
Representation of the company to customers and authorities
Coordination of the complaint management system
CAPA management
Management and coordination of the quality assurance department
Process validation and qualification for production of biocompatible single-use items according to ISO 10993 (IQ/OQ/PQ)
Cleanroom validation according to ISO 14644
Introduction of new in-process controls in manufacturing
Conducting internal and external audits (supplier audits)
Mar 2001 - Mar 2008
7 years 1 month
Munich, Germany
Headquarter Complaint Manager
Agfa Gevaert AG, Bereich Healthcare
Computed radiology, PACS (Picture Archiving and Communication System)
Facilitation among internal departments as well as with external interfaces
Introduction of global post-market surveillance processes (complaints, CAPA, etc.), including definition of parameters for inputs, outputs, and escalations
Streamlining complaint handling between local branches and headquarters
Development of statistics and trend reports for overall product quality analysis
Specification and implementation of a database for global complaint tracking
Measurement and monitoring of complaints with reporting to cross-department teams and management
Training on the CAPA process and the use of the complaint system
Analysis and measurement of process capability according to Six Sigma (Process FMEA, ANOVA, control charts, etc.)
Improvement of QMS processes using Six Sigma
Support for the introduction of computerized software validation (CSV)
Sep 1998 - Mar 2001
2 years 7 months
Munich, Germany
Product Specialist for 2nd Line Support
Agfa Gevaert AG, Bereich Healthcare
Computed radiology, PACS (Picture Archiving and Communication System)
2nd line support for Agfa branches, customers, and dealers
Field assignments for installations and service at customer or dealer sites
Conducting system and equipment training courses for branches, customers, and dealers
Development of course content and training materials
Collaboration on specifications, validation, and introduction of new products
Programming in Unix, assembler
Remote diagnosis of device faults via internet (VPN)
Sep 1993 - Aug 1998
5 years
Germany
Product Specialist, Auditor
TÜV Süd Produkt Service
Medical device approval, certification of medical device manufacturers
Coordinator for FDA 510(k) approvals
Central coordinator for medical device approvals in Japan
Auditor and lead auditor for QMS approvals according to ISO 9000/EN 46000, MDD, and AIMD in Europe, East Asia, and the USA
Expert for regulatory approval of medical devices (focus on extracorporeal circuits – blood cell separators, dialysis machines, heart-lung machines)
Testing of safety for medical electrical equipment according to IEC 60601-1
Testing of electromagnetic compatibility according to IEC 60601-1-2
Member of the CE certification committee
Summary
ISO 13485 auditor
Quality management according to ISO 13485, FDA 21 CFR 820, etc.