Medizintechnik, Medical Devices
Aktualisiert am 21.05.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.06.2025
Verfügbar zu: 100%
davon vor Ort: 100%
R&D
Quality Management
Regulatory Affairs
MDR
FDA
ISO 13485
21CFR820
ISO 14971
TechDoc
Risikomanagement
Design Control
Usability
Biocompatibility
ISO 62366
ISO 10993
Combination Products
Drug Delivery Devices
Product Development
Design Transfer
CAPA
Design Verification
Design Validation
Requirements Engineering

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 Monate
2024-11 - heute

Creating Risk Management Files

Consultant
Consultant
  • Creating Risk Management Files for opthalmic medical devices according to MDR
  • Risk Management according to ISO 14971, ISO 13485, MDR, IEC 60601-ff
  • Consulting Support on Design Control Documents to match ISO 13485 & MDSAP
SCHWIND Eye-Tech GmbH
Aschaffenburg
6 Jahre 5 Monate
2019-01 - heute

Consulting & support services

Consultant / Freelancer
Consultant / Freelancer
  • Consulting & support services for various medical device companies as a freelancer / medical device expert
5 Monate
2024-08 - 2024-12

Updating Design Control Documents

  • Design Control & Risk Management Expert for In-Vitro-Diagnostic Devices (IVDR)
  • Updating Risk Management Files within the transition from IVDD to IVDR
  • Updating Design Control Documents to match ISO 13485 & FDA 21CFR820
  • Support on Production FMEA, V&V, Usability, Clinical Evaluation, Change Control
Orgentec GmbH / Sebia S.A
Mainz, France
9 Monate
2024-04 - 2024-12

Developing design & regulatory strategies

Consultant
Consultant
  • Design Control Expert for drug delivery devices (auto-injectors & prefilled syringes)
  • Developing design & regulatory strategies for combination products
  • Managing development programs with internal & external stakeholders
  • Coordinating external partners (CMOs, CROs) & notified bodies
  • Creating design control documents for combination products
  • Support on Risk Management, V&V, Usability, Clinical Evaluation, Change Control
Formycon AG
Munich
9 Monate
2024-03 - 2024-11

Coaching of an international team

Consultant
Consultant
  • Regulatory Expert for an innovative inhalation system
  • Coaching of an international team in Germany & Turkey
  • Review & Update of MDR TechDoc & FDA 510k dossiers
  • Review & Update of Design History Files (DHF) 
CLARIO Inc. ? ERT GmbH
Würzburg
1 Jahr 3 Monate
2023-06 - 2024-08

Change Management & Process Management

Consultant
Consultant
  • QMS Transformation Project Lead
  • Change Management & Process Management
  • Establishing Design Control Procedures acc. to FDA 21CFR820, ISO 13485, MDSAP
  • Establishing Risk Management Procedures acc. to ISO 14971
  • Updating Design History Files (DHF) and Risk Management Files
  • CAPA Handling and Implementation
Dentsply Sirona GmbH
Bensheim
4 Monate
2023-12 - 2024-03

Coordination of innovation activities

Consultant
Consultant
  • Innovation manager for sustainable drug delivery devices
  • Coordination of innovation activities with internal & external stakeholders
  • Creating innovative concepts for eco-friendly & sustainable drug delivery devices
  • Regulatory aspects for innovative drug delivery devices (combination products)
  • Presentation of innovation activities & status reports to management board 
Boehringer Ingelheim AG
Ingelheim
5 Monate
2022-10 - 2023-02

Design History File

Consultant
Consultant
  • Design History File (DHF) Documentation of inhalation devices
  • Creating Verification & Validation (V&V) documents
  • Coordinating V&V activities with external test laboratories
  • Biocompatibility Evaluation acc. to ISO 10993
Resyca GmbH
Munich
2 Jahre
2020-11 - 2022-10

Usability Studies & Documentation

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Irrigation Solutions
  • Usability Studies & Documentation acc. to ISO 62366
  • Risk Management Documentation acc. to ISO14971
  • Requirement Management and DHF Documentation 
B.Braun AG
Melsungen
7 Monate
2021-09 - 2022-03

Creating MDR TechDoc

  • Consultant / Medical Device Expert
  • Creating MDR TechDoc for Optical Medical Devices
  • GSPR Documentation acc. to EU2017/745 (MDR)
  • Risk Management Files, Regulatory and Clinical Strategy Plan 
Carl Zeiss Vision GmbH
Aalen
1 Jahr 1 Monat
2021-03 - 2022-03

Creating FDA Design History Files

Consultant
Consultant
  • Consultant / Medical Device Expert
  • Creating FDA Design History Files (DHF) for Implantable Medical Devices
  • Writing Design Input & Design Output Docs for FDA DHF
  • Ensuring compliance according to relevant FDA regulations
Sequana Medical NV
Zurich
7 Monate
2021-06 - 2021-12

MDR TechDoc for Blood Processing Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Blood Processing Devices
  • Update / create technical documentation in compliance with (EU) MDR
  • Biocompatibility Reports, Clinical Evaluation Reports 
Haemonetics Corp.
Switzerland
1 Jahr 1 Monat
2020-12 - 2021-12

MDR TechDoc for Infusion Pumps & Drug Delivery Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Infusion Pumps & Drug Delivery Devices
  • Risk Management Documentation acc. to ISO 14971
  • Risk Management Files for MDR TechDoc
Becton Dickinson, BD
Ireland
5 Monate
2020-01 - 2020-05

MDR TechDoc for Radiation Therapy Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Radiation Therapy Devices
  • Risk Management Files, Usability, Biocompatibility, Clinical Evaluation, PMS
Brainlab AG
Munich
11 Monate
2019-02 - 2019-12

FDA Design History Files (DHF) Remediation

Consultant
Consultant
  • Consultant / Medical Device Expert
  • FDA Design History Files (DHF) Remediation
  • MDR Technical File Creation
LivaNova PLC
Munich

Aus- und Weiterbildung

Aus- und Weiterbildung

5 Jahre 7 Monate
1992-10 - 1998-04

University study / Mechanical Engineering

Diplom-Ingenieur (TU), TU Darmstadt (GERMANY) and ETH Zurich (Switzerland)
Diplom-Ingenieur (TU)
TU Darmstadt (GERMANY) and ETH Zurich (Switzerland)
  • Grade: ?good? (1,6) / Diploma thesis: ?very good? (1,0) 
1 Monat
1992-05 - 1992-05

University entrance diploma

Abitur, Gymnasium Philippinum (Weilburg, GERMANY)
Abitur
Gymnasium Philippinum (Weilburg, GERMANY)
  • Grade: ?very good? (1,5)

Kompetenzen

Kompetenzen

Top-Skills

R&D Quality Management Regulatory Affairs MDR FDA ISO 13485 21CFR820 ISO 14971 TechDoc Risikomanagement Design Control Usability Biocompatibility ISO 62366 ISO 10993 Combination Products Drug Delivery Devices Product Development Design Transfer CAPA Design Verification Design Validation Requirements Engineering

Produkte / Standards / Erfahrungen / Methoden

Work experience:

  • Member of the Executive Management Board
  • Chief Technology Officer (CTO)
  • Business Development Manager (BDM)
  • OEM-Business-Manager (Asia, Middle-East, Latin-America)
  • Project Manager
  • Process Manager
  • Innovation Manager
  • Patent Manager
  • R&D and Product Development Expert
  • Quality Management Expert & Representative
  • Auditor in Quality Management
  • Production & Supply Chain Management
  • Customer Service Management


Expertise:

  • More than 20 years of work experience in management and leadership
  • More than 20 years of work experience in the MedTech and Pharma industry
  • More than 20 years of work experience in leading international projects and interdisciplinary teams 


MedTech & Pharma Expertise (> 20 years):

  • Medical Devices, Pharma Products, Combination Products, Implants, Drug Delivery Devices & Technologies 


Consumer products Expertise (5 years):

  • Cameras, Lenses, Accessories, Consumer Electronics, Power Supply Units & Adapters


Miscellaneous Expertise & Professional Knowledge:

  • Business Model Generation, Corporate Change Management, Consulting, Life Sciences, Medical Technologies, Mechanics, Fluidics, Sensor Systems, Drive Systems, Mechanical Design, Simulation (FEM, CFD), Electronic Design, Software Engineering, Rapid Prototyping, OEM manufacturing

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 Monate
2024-11 - heute

Creating Risk Management Files

Consultant
Consultant
  • Creating Risk Management Files for opthalmic medical devices according to MDR
  • Risk Management according to ISO 14971, ISO 13485, MDR, IEC 60601-ff
  • Consulting Support on Design Control Documents to match ISO 13485 & MDSAP
SCHWIND Eye-Tech GmbH
Aschaffenburg
6 Jahre 5 Monate
2019-01 - heute

Consulting & support services

Consultant / Freelancer
Consultant / Freelancer
  • Consulting & support services for various medical device companies as a freelancer / medical device expert
5 Monate
2024-08 - 2024-12

Updating Design Control Documents

  • Design Control & Risk Management Expert for In-Vitro-Diagnostic Devices (IVDR)
  • Updating Risk Management Files within the transition from IVDD to IVDR
  • Updating Design Control Documents to match ISO 13485 & FDA 21CFR820
  • Support on Production FMEA, V&V, Usability, Clinical Evaluation, Change Control
Orgentec GmbH / Sebia S.A
Mainz, France
9 Monate
2024-04 - 2024-12

Developing design & regulatory strategies

Consultant
Consultant
  • Design Control Expert for drug delivery devices (auto-injectors & prefilled syringes)
  • Developing design & regulatory strategies for combination products
  • Managing development programs with internal & external stakeholders
  • Coordinating external partners (CMOs, CROs) & notified bodies
  • Creating design control documents for combination products
  • Support on Risk Management, V&V, Usability, Clinical Evaluation, Change Control
Formycon AG
Munich
9 Monate
2024-03 - 2024-11

Coaching of an international team

Consultant
Consultant
  • Regulatory Expert for an innovative inhalation system
  • Coaching of an international team in Germany & Turkey
  • Review & Update of MDR TechDoc & FDA 510k dossiers
  • Review & Update of Design History Files (DHF) 
CLARIO Inc. ? ERT GmbH
Würzburg
1 Jahr 3 Monate
2023-06 - 2024-08

Change Management & Process Management

Consultant
Consultant
  • QMS Transformation Project Lead
  • Change Management & Process Management
  • Establishing Design Control Procedures acc. to FDA 21CFR820, ISO 13485, MDSAP
  • Establishing Risk Management Procedures acc. to ISO 14971
  • Updating Design History Files (DHF) and Risk Management Files
  • CAPA Handling and Implementation
Dentsply Sirona GmbH
Bensheim
4 Monate
2023-12 - 2024-03

Coordination of innovation activities

Consultant
Consultant
  • Innovation manager for sustainable drug delivery devices
  • Coordination of innovation activities with internal & external stakeholders
  • Creating innovative concepts for eco-friendly & sustainable drug delivery devices
  • Regulatory aspects for innovative drug delivery devices (combination products)
  • Presentation of innovation activities & status reports to management board 
Boehringer Ingelheim AG
Ingelheim
5 Monate
2022-10 - 2023-02

Design History File

Consultant
Consultant
  • Design History File (DHF) Documentation of inhalation devices
  • Creating Verification & Validation (V&V) documents
  • Coordinating V&V activities with external test laboratories
  • Biocompatibility Evaluation acc. to ISO 10993
Resyca GmbH
Munich
2 Jahre
2020-11 - 2022-10

Usability Studies & Documentation

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Irrigation Solutions
  • Usability Studies & Documentation acc. to ISO 62366
  • Risk Management Documentation acc. to ISO14971
  • Requirement Management and DHF Documentation 
B.Braun AG
Melsungen
7 Monate
2021-09 - 2022-03

Creating MDR TechDoc

  • Consultant / Medical Device Expert
  • Creating MDR TechDoc for Optical Medical Devices
  • GSPR Documentation acc. to EU2017/745 (MDR)
  • Risk Management Files, Regulatory and Clinical Strategy Plan 
Carl Zeiss Vision GmbH
Aalen
1 Jahr 1 Monat
2021-03 - 2022-03

Creating FDA Design History Files

Consultant
Consultant
  • Consultant / Medical Device Expert
  • Creating FDA Design History Files (DHF) for Implantable Medical Devices
  • Writing Design Input & Design Output Docs for FDA DHF
  • Ensuring compliance according to relevant FDA regulations
Sequana Medical NV
Zurich
7 Monate
2021-06 - 2021-12

MDR TechDoc for Blood Processing Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Blood Processing Devices
  • Update / create technical documentation in compliance with (EU) MDR
  • Biocompatibility Reports, Clinical Evaluation Reports 
Haemonetics Corp.
Switzerland
1 Jahr 1 Monat
2020-12 - 2021-12

MDR TechDoc for Infusion Pumps & Drug Delivery Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Infusion Pumps & Drug Delivery Devices
  • Risk Management Documentation acc. to ISO 14971
  • Risk Management Files for MDR TechDoc
Becton Dickinson, BD
Ireland
5 Monate
2020-01 - 2020-05

MDR TechDoc for Radiation Therapy Devices

Consultant
Consultant
  • Consultant / Medical Device Expert
  • MDR TechDoc for Radiation Therapy Devices
  • Risk Management Files, Usability, Biocompatibility, Clinical Evaluation, PMS
Brainlab AG
Munich
11 Monate
2019-02 - 2019-12

FDA Design History Files (DHF) Remediation

Consultant
Consultant
  • Consultant / Medical Device Expert
  • FDA Design History Files (DHF) Remediation
  • MDR Technical File Creation
LivaNova PLC
Munich

Aus- und Weiterbildung

Aus- und Weiterbildung

5 Jahre 7 Monate
1992-10 - 1998-04

University study / Mechanical Engineering

Diplom-Ingenieur (TU), TU Darmstadt (GERMANY) and ETH Zurich (Switzerland)
Diplom-Ingenieur (TU)
TU Darmstadt (GERMANY) and ETH Zurich (Switzerland)
  • Grade: ?good? (1,6) / Diploma thesis: ?very good? (1,0) 
1 Monat
1992-05 - 1992-05

University entrance diploma

Abitur, Gymnasium Philippinum (Weilburg, GERMANY)
Abitur
Gymnasium Philippinum (Weilburg, GERMANY)
  • Grade: ?very good? (1,5)

Kompetenzen

Kompetenzen

Top-Skills

R&D Quality Management Regulatory Affairs MDR FDA ISO 13485 21CFR820 ISO 14971 TechDoc Risikomanagement Design Control Usability Biocompatibility ISO 62366 ISO 10993 Combination Products Drug Delivery Devices Product Development Design Transfer CAPA Design Verification Design Validation Requirements Engineering

Produkte / Standards / Erfahrungen / Methoden

Work experience:

  • Member of the Executive Management Board
  • Chief Technology Officer (CTO)
  • Business Development Manager (BDM)
  • OEM-Business-Manager (Asia, Middle-East, Latin-America)
  • Project Manager
  • Process Manager
  • Innovation Manager
  • Patent Manager
  • R&D and Product Development Expert
  • Quality Management Expert & Representative
  • Auditor in Quality Management
  • Production & Supply Chain Management
  • Customer Service Management


Expertise:

  • More than 20 years of work experience in management and leadership
  • More than 20 years of work experience in the MedTech and Pharma industry
  • More than 20 years of work experience in leading international projects and interdisciplinary teams 


MedTech & Pharma Expertise (> 20 years):

  • Medical Devices, Pharma Products, Combination Products, Implants, Drug Delivery Devices & Technologies 


Consumer products Expertise (5 years):

  • Cameras, Lenses, Accessories, Consumer Electronics, Power Supply Units & Adapters


Miscellaneous Expertise & Professional Knowledge:

  • Business Model Generation, Corporate Change Management, Consulting, Life Sciences, Medical Technologies, Mechanics, Fluidics, Sensor Systems, Drive Systems, Mechanical Design, Simulation (FEM, CFD), Electronic Design, Software Engineering, Rapid Prototyping, OEM manufacturing

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