Quality Management and Regulatory Affairs of Medical Devices and IVDs
Aktualisiert am 21.08.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 11.07.2024
Verfügbar zu: 100%
davon vor Ort: 35%
Technical Documentation
Regulatory Affairs
MDR/IVDR
Risikomanagement
Clinical Evaluation
Performance Evaluation
Biological Evaluation
Usability
Audits
510(k) / De Novo
Stability
German
Fluent
English
Fluent
French
proficient
Spanish
basic knowledge
Latin
basic knowledge

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 Jahre
2017-10 - heute

MDD + ISO 13485

Senior Consultant, Freelancer and Auditor
Senior Consultant, Freelancer and Auditor
  • revision of customer?s clinical evaluations, risk/usability and biocompatibility analysis
  • performing audits and preparation of a checklist for ISO 13485:2016 audits
  • products: products for ingestion, IVD, orthopedic products + various others especially in audits
ecm and TÜV Nord
Steinfurt, Würselen, and Koblenz, Germany
3 Jahre 8 Monate
2020-10 - 2024-05

Technical Documentation for Medical Devices for Ingestion

  • clinical evaluations
  • risk analysis
  • usabilities
  • biological evaluations
  • other support
1 Monat
2024-04 - 2024-04

International Internal Audit

MD Manufacturer
2 Jahre 1 Monat
2018-05 - 2020-05

Development of an audit checklist for MDR + ISO 13485:2016

Deputy Technical Director, Lead Auditor and Technical Expert
Deputy Technical Director, Lead Auditor and Technical Expert
  • MDR application as Notified Body: preparation of forms + SOPs
  • development of an audit checklist for MDR + ISO 13485:2016
  • audits and evaluations of technical documentations acc. to MDD (and ISO 13485)
  • products: various medical devices from class I to class III
ECM
Aachen, Germany
4 Monate
2017-06 - 2017-09

Preparation for MDR incl. UDI

Head of QM and RA (2 co-workers and various consultants worldwide)
Head of QM and RA (2 co-workers and various consultants worldwide)
  • preparation for MDR incl. UDI
  • performing detailed risk analysis (ISO 14971) and biocomp. strategy (ISO 10993 & 18562)
  • introduction of an extensive ultra-sonic cleaning strategy
  • products: anesthesia, ventilation, inhalation and patient monitoring devices
HEYER Medical
Bad Ems, Germany
1 Jahr 1 Monat
2016-05 - 2017-05

Responsible for license applications

Regulatory Affairs Manager
Regulatory Affairs Manager
  • responsible for license applications (incl. 510k) and support in the US, Japan, Canada, ?
  •  internal consultant: supporting a newly acquired company in the US by further developing their technical documentation (e.g. risk & usability analysis) and improving their QM system
  • introduction of UDI for US market
  • products: about 30.000 products concerning wound care, surgery, and compression/bandage
Lohmann & Rauscher GmbH
Neuwied, Germany
3 Monate
2015-10 - 2015-12

Performing extensive risk analysis

Head of QM and RA (3 co-workers and various consultants worldwide)
Head of QM and RA (3 co-workers and various consultants worldwide)
  • responsible for QM and worldwide license applications and license support
  • performing extensive risk analysis (ISO 14971) for the products
  • responsible for external audits (passed an audit by the notified body in November)
  • products: about 1600 endoscopic spinal surgery products including implants
joimax GmbH
Karlsruhe, Germany
1 Jahr 4 Monate
2014-06 - 2015-09

Responsible for worldwide license applications and license support

Head of Regulatory Affairs (2 co-workers + 2 students and various consultants worldwide)
Head of Regulatory Affairs (2 co-workers + 2 students and various consultants worldwide)
  • responsible for worldwide license applications and license support in more than 70 countries
  • performing extensive risk (ISO 14971) and usability analysis (IEC 62366)
  • products: dental alloys and ceramics as well as 3D resins and various dental materials
BEGO Bremer Goldschägerei GmbH & Co. KG
Bremen, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2021-07 - 2021-07

Lead Auditor ISO 13485

Certificate, BSI
Certificate
BSI
1 Jahr 9 Monate
1991-12 - 1993-08

Postdoc

University of Colorado, Boulder, CO, USA
University of Colorado, Boulder, CO, USA
  • Analytical and Atmospheric Chemistry
  • Theme on request

7 Jahre 1 Monat
1984-10 - 1991-10

Study of Chemistry

Ph.D. degree in Analytical Chemistry, "magna cum laude", Westfälische Wilhelms-Universität Münster, Germany
Ph.D. degree in Analytical Chemistry, "magna cum laude"
Westfälische Wilhelms-Universität Münster, Germany
  • Thesis on request
4 Jahre 8 Monate
1984-10 - 1989-05

Studies Analytical Chemistry

Diploma degree (? master degree) in chemistry, Münster University
Diploma degree (? master degree) in chemistry
Münster University

Position

Position

  • Freelancer im Qualitätsmanagement, Regulatory Affairs, Technische Dokumentation im Bereich Medizinprodukte und In-vitro-Diagnostika

Kompetenzen

Kompetenzen

Top-Skills

Technical Documentation Regulatory Affairs MDR/IVDR Risikomanagement Clinical Evaluation Performance Evaluation Biological Evaluation Usability Audits 510(k) / De Novo Stability

Schwerpunkte

Clinical Evaluation of Medical Devices
Experte
Risk Management of Medical Devices and IVDs
Experte
Biological Evaluation of Medical Devices
Experte
Usability of Medical Devices
Experte
Performance Evaluation of IVDs
Experte

Produkte / Standards / Erfahrungen / Methoden

WinWord
Excel
PowerPoint
Regulatory Affairs / Quality Management in Medical Device / IVD area
  • Deputy Techn. Director (ecm), Auditor and Technical Expert (ecm + TÜV Nord (external))
  • RA / QM manager / consultant for more than 16 years in various IVD and MD companies
  • performing clinical evaluations, biocompatibility, risk + usability analysis
  • FDA clearances (IVD) as Project Manager for DeNovo 510(k) and traditional 510(k) incl. direct negotiations with FDA
  • worldwide licences for IVDs, chemical, biological, endoscopic and dental products as well as software and instruments (e.g. CFDA and 30+ class II and III licences in Canada)
  • ISO 13485, 14971 + 10993, EC MDR and IVDR, US 21 CFR Part 820, Canadian MDR
  • forming and leading regulatory affairs / quality management departments


Work Experience:

10/2017 - today

Role: Consultant ? Freelancer

Customer: on request


05/2018 - 05/2020

Role: Deputy Technical Director

Customer: ECM, Aachen


06/2017 - 09/2017

Role: Head of RA & QM

Customer: HEYER Medical AG, Bad Ems


05/2016 - 05/2017

Role: Regulatory Affairs Manager

Customer: Lohmann & Rauscher GmbH & Co. KG, Neuwied


10/2015 - 12/2015

Role: Head of QM & RA

Customer: joimax GmbH, Karlsruhe


06/2014 - 09/2015

Role: Head of Regulatory Affairs

Customer: BEGO Bremer Goldschlägerei GmbH, Bremen


02/2011 - 05/2014

Role: Regulatory Affairs Manager (IVD)

Customer: Bruker Daltonik GmbH, Bremen


11/2005 - 01/2011

Role: Head of Regulatory Affairs and QM Representative (IVD)

Customer: Chromsystems Instruments & Chemicals GmbH, Munich


04/1998 - 10/2005

Role: Project Manager Technical Documentation

Customer: Dionex Softron GmbH, Germering, Bavaria


09/1997 - 03/1998

Role: IVD Research & Development 

Customer: Roche Diagnostics GmbH / Boehringer Mannheim, Tutzing


08/1994 - 09/1996

Role: Head of Laboratories and Scientist

Customer: Research Center Jülich (KFA), NRW

Riskmanagement

Risk Management of Medical Devices and IVDs
Experte

Regulatory Affairs

FDA applications (510(k) / DeNovo)
Experte
Health Canada applications
Experte
CFDA applications
Fortgeschritten
Communication with other authorities like ANSM and Swissmedic
Experte

Branchen

Branchen

  • Medical Devices and In-vitro-Diagnostics

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 Jahre
2017-10 - heute

MDD + ISO 13485

Senior Consultant, Freelancer and Auditor
Senior Consultant, Freelancer and Auditor
  • revision of customer?s clinical evaluations, risk/usability and biocompatibility analysis
  • performing audits and preparation of a checklist for ISO 13485:2016 audits
  • products: products for ingestion, IVD, orthopedic products + various others especially in audits
ecm and TÜV Nord
Steinfurt, Würselen, and Koblenz, Germany
3 Jahre 8 Monate
2020-10 - 2024-05

Technical Documentation for Medical Devices for Ingestion

  • clinical evaluations
  • risk analysis
  • usabilities
  • biological evaluations
  • other support
1 Monat
2024-04 - 2024-04

International Internal Audit

MD Manufacturer
2 Jahre 1 Monat
2018-05 - 2020-05

Development of an audit checklist for MDR + ISO 13485:2016

Deputy Technical Director, Lead Auditor and Technical Expert
Deputy Technical Director, Lead Auditor and Technical Expert
  • MDR application as Notified Body: preparation of forms + SOPs
  • development of an audit checklist for MDR + ISO 13485:2016
  • audits and evaluations of technical documentations acc. to MDD (and ISO 13485)
  • products: various medical devices from class I to class III
ECM
Aachen, Germany
4 Monate
2017-06 - 2017-09

Preparation for MDR incl. UDI

Head of QM and RA (2 co-workers and various consultants worldwide)
Head of QM and RA (2 co-workers and various consultants worldwide)
  • preparation for MDR incl. UDI
  • performing detailed risk analysis (ISO 14971) and biocomp. strategy (ISO 10993 & 18562)
  • introduction of an extensive ultra-sonic cleaning strategy
  • products: anesthesia, ventilation, inhalation and patient monitoring devices
HEYER Medical
Bad Ems, Germany
1 Jahr 1 Monat
2016-05 - 2017-05

Responsible for license applications

Regulatory Affairs Manager
Regulatory Affairs Manager
  • responsible for license applications (incl. 510k) and support in the US, Japan, Canada, ?
  •  internal consultant: supporting a newly acquired company in the US by further developing their technical documentation (e.g. risk & usability analysis) and improving their QM system
  • introduction of UDI for US market
  • products: about 30.000 products concerning wound care, surgery, and compression/bandage
Lohmann & Rauscher GmbH
Neuwied, Germany
3 Monate
2015-10 - 2015-12

Performing extensive risk analysis

Head of QM and RA (3 co-workers and various consultants worldwide)
Head of QM and RA (3 co-workers and various consultants worldwide)
  • responsible for QM and worldwide license applications and license support
  • performing extensive risk analysis (ISO 14971) for the products
  • responsible for external audits (passed an audit by the notified body in November)
  • products: about 1600 endoscopic spinal surgery products including implants
joimax GmbH
Karlsruhe, Germany
1 Jahr 4 Monate
2014-06 - 2015-09

Responsible for worldwide license applications and license support

Head of Regulatory Affairs (2 co-workers + 2 students and various consultants worldwide)
Head of Regulatory Affairs (2 co-workers + 2 students and various consultants worldwide)
  • responsible for worldwide license applications and license support in more than 70 countries
  • performing extensive risk (ISO 14971) and usability analysis (IEC 62366)
  • products: dental alloys and ceramics as well as 3D resins and various dental materials
BEGO Bremer Goldschägerei GmbH & Co. KG
Bremen, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2021-07 - 2021-07

Lead Auditor ISO 13485

Certificate, BSI
Certificate
BSI
1 Jahr 9 Monate
1991-12 - 1993-08

Postdoc

University of Colorado, Boulder, CO, USA
University of Colorado, Boulder, CO, USA
  • Analytical and Atmospheric Chemistry
  • Theme on request

7 Jahre 1 Monat
1984-10 - 1991-10

Study of Chemistry

Ph.D. degree in Analytical Chemistry, "magna cum laude", Westfälische Wilhelms-Universität Münster, Germany
Ph.D. degree in Analytical Chemistry, "magna cum laude"
Westfälische Wilhelms-Universität Münster, Germany
  • Thesis on request
4 Jahre 8 Monate
1984-10 - 1989-05

Studies Analytical Chemistry

Diploma degree (? master degree) in chemistry, Münster University
Diploma degree (? master degree) in chemistry
Münster University

Position

Position

  • Freelancer im Qualitätsmanagement, Regulatory Affairs, Technische Dokumentation im Bereich Medizinprodukte und In-vitro-Diagnostika

Kompetenzen

Kompetenzen

Top-Skills

Technical Documentation Regulatory Affairs MDR/IVDR Risikomanagement Clinical Evaluation Performance Evaluation Biological Evaluation Usability Audits 510(k) / De Novo Stability

Schwerpunkte

Clinical Evaluation of Medical Devices
Experte
Risk Management of Medical Devices and IVDs
Experte
Biological Evaluation of Medical Devices
Experte
Usability of Medical Devices
Experte
Performance Evaluation of IVDs
Experte

Produkte / Standards / Erfahrungen / Methoden

WinWord
Excel
PowerPoint
Regulatory Affairs / Quality Management in Medical Device / IVD area
  • Deputy Techn. Director (ecm), Auditor and Technical Expert (ecm + TÜV Nord (external))
  • RA / QM manager / consultant for more than 16 years in various IVD and MD companies
  • performing clinical evaluations, biocompatibility, risk + usability analysis
  • FDA clearances (IVD) as Project Manager for DeNovo 510(k) and traditional 510(k) incl. direct negotiations with FDA
  • worldwide licences for IVDs, chemical, biological, endoscopic and dental products as well as software and instruments (e.g. CFDA and 30+ class II and III licences in Canada)
  • ISO 13485, 14971 + 10993, EC MDR and IVDR, US 21 CFR Part 820, Canadian MDR
  • forming and leading regulatory affairs / quality management departments


Work Experience:

10/2017 - today

Role: Consultant ? Freelancer

Customer: on request


05/2018 - 05/2020

Role: Deputy Technical Director

Customer: ECM, Aachen


06/2017 - 09/2017

Role: Head of RA & QM

Customer: HEYER Medical AG, Bad Ems


05/2016 - 05/2017

Role: Regulatory Affairs Manager

Customer: Lohmann & Rauscher GmbH & Co. KG, Neuwied


10/2015 - 12/2015

Role: Head of QM & RA

Customer: joimax GmbH, Karlsruhe


06/2014 - 09/2015

Role: Head of Regulatory Affairs

Customer: BEGO Bremer Goldschlägerei GmbH, Bremen


02/2011 - 05/2014

Role: Regulatory Affairs Manager (IVD)

Customer: Bruker Daltonik GmbH, Bremen


11/2005 - 01/2011

Role: Head of Regulatory Affairs and QM Representative (IVD)

Customer: Chromsystems Instruments & Chemicals GmbH, Munich


04/1998 - 10/2005

Role: Project Manager Technical Documentation

Customer: Dionex Softron GmbH, Germering, Bavaria


09/1997 - 03/1998

Role: IVD Research & Development 

Customer: Roche Diagnostics GmbH / Boehringer Mannheim, Tutzing


08/1994 - 09/1996

Role: Head of Laboratories and Scientist

Customer: Research Center Jülich (KFA), NRW

Riskmanagement

Risk Management of Medical Devices and IVDs
Experte

Regulatory Affairs

FDA applications (510(k) / DeNovo)
Experte
Health Canada applications
Experte
CFDA applications
Fortgeschritten
Communication with other authorities like ANSM and Swissmedic
Experte

Branchen

Branchen

  • Medical Devices and In-vitro-Diagnostics

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