Senior RA/QA Consultant, Lead Auditor EN ISO 13485 & ISO/IEC 27001

1/2021 – 12/2024

• Update of QM procedures
• Process validation
• MDR / IVDR remediation
• Update Technical Documentation
• CE approval process including device launch

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485

3/2020 – 12/2022

• Update of QM procedures
• UDI compliance EU
• Label-Change process
• Implementation of UDI procedures
• Supplier qualification (UDI)

Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

3/2019 – 12/2022

• Update of QM procedures
• UDI compliance EU
• Label-Change process
• Implementation of UDI procedures
• Supplier qualification (UDI)
• UDI compliance, international

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485

3/2017 – 6/2019

• Regulatory responsible within new development project (class III implantable medical device)
• CE approval process including device launch

Medizintechnik, Regulatory Affairs Manager, Projektmanagement

3/2017 – 3/2018

Implementation of QM-System according to EN ISO 13485

Medizintechnik, Projektmanagement, Auditor, DIN EN ISO 13485

9/2016 – 12/2024

• Team lead: Review of technical files
• updating the technical file
• CE approval process including device launch
• International Registration of the medical devices
• General consulting regarding EU and international medical device compliance
• MDR remediation
• UDI requirements
• Implementation of QM-System according to EN ISO 13485:2016
• Process validation

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485

7/2015 – 1/2018

• Approval strategies for a medical device
• Review of technical files
• updating the technical file
• General consulting regarding EU and international medical device compliance

Medizintechnik, Regulatory Affairs Manager, Projektmanagement

3/2015 – 12/2019

• Review of technical documentation
• GAP analysis
• updating the technical file
• Preparing STED format
• Technical File Update Project (MDR)

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

12/2014 – 9/2016

• Update of QM procedures
• Process validation
• UDI compliance FDA
• Label-Change process
• Implementation of UDI procedures
• Supplier qualification (UDI)
• QM-Remediation

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

7/2014 – 7/2015

• implementing a quality management system
• CSV

Auditor, DIN EN ISO 13485, Projektmanagement, Qualitätsmanagement (allg.)

7/2014 – 3/2015

• implementing a quality management system
• Approval strategies for a new medical device (IVD)
• preparing and review of technical files
• Conducting supplier audits

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

7/2013 – 12/2023

• implementing a quality management system
• Process validation
• Approval strategies for new medical devices
• preparing and review of technical files
• CE approval process
• Conducting internal audits and supplier audits
• Update of QM-System according to EN ISO 13485:2016
• Update of QM-System according to MDR requirements
• Remediation of technical documentation for MDR compliance including device launch

Auditor, DIN EN ISO 13485, Medizintechnik, Qualitätsmanagement (allg.), Regulatory Affairs Manager

1/2013 – 6/2016

• implementing a quality management system
• Process validation
• Approval strategies for new medical devices
• preparing and review of technical files
• Conducting supplier audits

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485

1/2012 – 9/2023

• Review of technical files,
• Approval strategies for new medical devices
• CE approval process
• Conducting internal audits and supplier audits
• Update of QM-System according to EN ISO 13485:2016
• Update of QM-System according to MDR requirements
• Process validation
• Remediation of technical documentation for MDR compliance including device launch

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

1/2012 – 6/2021

• implementing a quality management system
• Process validation
• Review of technical files
• Approval strategies for new medical devices
• CE approval process including device launch
• Strategic Planning for clinical studies
• Update of QM-System according to EN ISO 13485:2016
• Conducting internal audits and supplier audits
• international approval and registration processes

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

8/2011 – 11/2014

• implementing a quality management system
• Process validation
• Review of technical files
• CSV
• Approval strategies for new medical devices
• CE approval process including device launch
• international approval and registration processes

Auditor, DIN EN ISO 13485, Medizintechnik, Regulatory Affairs Manager

5/2011 – 12/2023

• implementing a quality management system
• Review of technical files,
• Approval strategies for new medical devices
• CE approval process EN ISO 13485
• Conducting internal audits and supplier audits
• Update of QM-System according to EN ISO 13485:2016
• Update of QM-System according to MDR requirements
• Remediation of technical documentation for MDR compliance

Medizintechnik, Projektmanagement, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.), Regulatory Affairs Manager

5/2011 – 12/2014

• implementing a quality management system
• Review of technical files,
• Approval strategies for new medical devices
• CE approval process
• Conducting internal audits and supplier audits
• international approval and registration processes

Auditor, DIN EN ISO 13485, Medizintechnik, Projektmanagement, Qualitätsmanagement (allg.), Regulatory Affairs Manager

5/2011 – 12/2011

• Conducting internal audits and supplier audits
• Review of technical files
• Approval strategies for new medical devices
• CE approval process

Medizintechnik, Auditor, DIN EN ISO 13485, Qualitätsmanagement (allg.)

2/2008 – 4/2011

• Assistance during the CE approval process for medical devices, including IVD devices and active implantable devices
• Implementation of Quality Management System (EN ISO 13485)
• Project- and Risk-Management
• Safety officer for medical devices
• Preparation and review of technical files
• Assistance by clinical studies
• Assistance of international medical device manufacturers located outside the EEA regarding the Medical Device Vigilance System (Authorized Representative), for all medical devices, class I, IIa, IIb, III, IVD, AIMD)
• Incident and Filed Safety Corrective Action (Recall) reporting; correspondence with the competent authorities within the EEA;

Medizintechnik, Regulatory Affairs, Auditor, DIN EN ISO 13485

5/2007 – 1/2008

• Assistance with the research and development of dental implants, prosthetic, and a small active prosthetic
• Supplier audits
• Preparation of technical files
• Implementation of Quality Management System (EN ISO 13485)
• Project- and Risk-Management (EN ISO 14971)
• Regulatory Affairs
• Safety officer for medical devices

Medizintechnik, Regulatory Affairs Manager, DIN EN ISO 13485, Qualitätsmanagement (allg.)

1/2000 – 4/2007

• Coordination and execution of different R&D projects
• Project Management
• Risk- and Quality Management
• Regulatory affairs, active and non-active products
• Clinical studies
• Technical consulting
• Usability-Engineering

Medizintechnik, Regulatory Affairs Manager, Projektmanagement, DIN EN ISO 13485