Quality, Regulatory & Risk Management für Medizinprodukte | ISO 13485, MDR, ISO 14971 | 10+ Jahre Erfahrung
Aktualisiert am 10.08.2026
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Verfügbar ab: 10.08.2026
Verfügbar zu: 100%
davon vor Ort: 100%
ISO 14971 Risikomanagement
ISO 13485 QMS
MDR (EU) 2017/745
Design Control
EN 62304
EN 60601-1
FDA 21 CFR Part 820
Audits (interne & externe)
Technische Dokumentation
Usability Engineering (IEC 62366)
Projektmanagement Medizinprodukte
English
Business fluent
Russian
Proficient
French
Beginner

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

5 Monate
2026-04 - heute

Conduct ISO 14971 risk analyses

Independent Consultant
Independent Consultant
  • Conduct ISO 14971 risk analyses and usability file reviews for active medical devices in ENT diagnostics, ensuring regulatory compliance and audit readiness 
Self-Employed
1 Jahr 3 Monate
2025-06 - heute

Responsible for the development of an electronic measuring neuro-implant

Director Software & Electronics Development
Director Software & Electronics Development
  • Lead 3 cross-functional teams (17 members) spanning app development, embedded software, and electronics engineering 
  • Responsible for the development of an electronic measuring neuro-implant with wearable and app integration, achieving CE certification and advancing FDA De Novo submission 
  • Responsible for integrating ISO 14971 risk management into design control across the teams, including FMEA and residual risk evaluation ahead of CE certification 
  • Lead a funded R&D initiative for a smart neuro-implant to treat hydrocephalus 
  • Lead organization-wide rollout of a data-driven electronic quality management system (e-QMS), currently in implementation 
Christoph Miethke GmbH, Potsdam
1 Jahr 8 Monate
2023-10 - 2025-05

Responsible for ISO 14971 risk management support

Director Projektmanagement, Quality & Regulatory
Director Projektmanagement, Quality & Regulatory
  • Manage two teams ? Project Management and Quality & Regulatory ? totaling 8 employees 
  • Serve as Project Manager for the development of a Class IIA active, cloud-connected measuring device with a team of 30+, leading registrations in the EU, US, and China and securing successful 510(k) clearance 
  • Act as Management Representative for a TÜV SÜD-certified ISO 13485 QMS (Scope: Design and Development), achieving zero findings in an audit 
  • Responsible for ISO 14971 risk management support across client projects, ensuring risk-based decision-making in design and development 
D.med Consulting, Hamburg
10 Monate
2023-01 - 2023-10

Support ISO 14971 risk management considerations

Head of Quality & Regulatory
Head of Quality & Regulatory
  • Manage the Quality & Regulatory team of 3 employees 
  • Serve as Project Manager for the development of a Class IIA active, cloud-connected measuring device with a team of 30+, leading registrations in the EU, US, and China 
  • Support market access strategies and MDR gap analyses for QMS and technical documentation across multiple medical devices and client portfolios 
  • Support ISO 14971 risk management considerations as part of MDR gap analyses and technical documentation reviews 
  • Act as Management Representative for a TÜV SÜD-certified ISO 13485 QMS (Scope: Design and Development) 
D.med Consulting, Hamburg
2 Jahre 8 Monate
2020-05 - 2022-12

Ensured Quality Assurance for dialysis machine manufacturers

Quality Assurance and Regulatory Affairs Manager
Quality Assurance and Regulatory Affairs Manager
  • Ensured Quality Assurance for dialysis machine manufacturers, by achieving compliance and audit readiness 
  • Optimize engineering systems for design & development processes, tools, and methods, improving efficiency and traceability for client organizations 
  • Provide strategic consulting and deputy project management on regulatory requirements in the Asia-Pacific region, enabling clients to navigate complex multi-market approval pathways 
  • Advise dialysis machine manufacturers on ISO 14971 risk management processes, ensuring risk controls are documented and verified prior to regulatory submission 
  • Conduct design verification of a ventilator, including verification of risk control measures, supporting successful regulatory submission 
  • Develop market access strategy for a non-active medical device, accelerating time-to-market for the client 
  • Support business development, sales, and marketing initiatives, contributing to client acquisition and portfolio growth 
qtec Services GmbH, Remote
2 Jahre 1 Monat
2018-04 - 2020-04

Create, review, and update technical documentation in STED format

Quality and Regulatory Affairs Manager
Quality and Regulatory Affairs Manager
  • Implement and maintain a full ISO 13485 QMS for the world market leader in practice hygiene and sterilization technology 
  • Establish and maintain the ISO 14971 risk management process as a core component of the QMS, ensuring risk management files support global product registrations 
  • Lead international product registrations in Japan, Australia, China, Russia, Singapore, and beyond, covering both active and non-active medical devices, supporting the company's global export footprint across 80+ countries 
  • Manage audits (e.g., EN ISO 13485, MDD, PED, KGMP, LAGeSo inspection) 
  • Create, review, and update technical documentation in STED format 
MELAG Medizintechnik, Berlin
5 Monate
2017-11 - 2018-03

Assist with preparation and follow-up of internal and external audits

Working Student - Quality management
Working Student - Quality management
  • Support the Quality Management department in maintaining ISO 13485 documentation 
  • Support maintenance of risk management documentation under ISO 14971 
  • Assist with preparation and follow-up of internal and external audits 
  • Contribute to the review and update of technical documentation 
  • Support daily QM processes and administrative tasks within the department 
MELAG Medizintechnik, Berlin
8 Monate
2017-02 - 2017-09

Develop and program a software application

Master Thesis
Master Thesis
  • Master's thesis: "on request" 
  • Develop and program a software application to support dialogue-based quality methods in incoming goods inspection 
  • Perform software validation and successfully introduce the application into company use 
  • Collaborate with cross-functional stakeholders to design and validate the approach for process improvement 
Philips Medical Systems, Hamburg
6 Monate
2016-08 - 2017-01

Support the Operations Quality department

Intern
Intern
  • Support the Operations Quality department in the production of X-ray and CT tubes 
  • Assist with quality control and inspection processes during manufacturing 
  • Contribute to documentation and compliance activities within a regulated production environment
Philips Medical Systems, Hamburg
11 Monate
2015-09 - 2016-07

Support process and document management

Working Student - Process and Document Management
Working Student - Process and Document Management
  • Support process and document management using the Method Park Stages tool 
  • Assist in modeling, documenting, and maintaining organizational processes 
  • Contribute to process compliance and continuous improvement initiatives 
IAV, Berlin

Aus- und Weiterbildung

Aus- und Weiterbildung

06/2008

Abitur

Johann-Rist-Gymnasium, Wedel


09/2015

Bachelor of Science Industrial Engineering and Management

Technical University Berlin

Specialization in Mechanical Engineering


03/2018

Master of Science Industrial Engineering and Management

Technical University Berlin

Specialization in Biomedical Technology


CERTIFICATIONS

  • ISTQB Certified Tester - Foundation Level
  • DGQ Quality Systems Manager Junior
  • Six Sigma Green Belt
  • Risk Management Training
  • Lean Management Training
  • DIN Standardization Expert Module 1 (Principles of Standardization)

Kompetenzen

Kompetenzen

Top-Skills

ISO 14971 Risikomanagement ISO 13485 QMS MDR (EU) 2017/745 Design Control EN 62304 EN 60601-1 FDA 21 CFR Part 820 Audits (interne & externe) Technische Dokumentation Usability Engineering (IEC 62366) Projektmanagement Medizinprodukte

Produkte / Standards / Erfahrungen / Methoden

SUMMARY

  • Quality, Regulatory & Project Management professional with 10+ years of experience in the medical device industry, spanning active implantable devices, dialysis systems, ventilators, and sterilization technology. Experience leading cross-functional teams and supporting international product registrations (EU, US, China, Japan, and beyond), CE certifications, and ISO 13485 QMS implementation. Combines technical and regulatory expertise with project leadership to support compliant, market-ready medical devices from concept to launch. 
  • Risk management is a core element of medical device development and has been a consistent focus throughout my career ? from establishing ISO 14971 risk management processes within QMS frameworks to independently preparing device-specific risk analyses supporting design control and regulatory submissions. 


SKILLS

IT:

  • Microsoft Office (Teams, Word, Excel, PowerPoint, Project, Visio)
  • Asana
  • MatrixReq
  • PTC Windchill
  • Siemens Polarion
  • Enterprise Architect
  • Method Park Stages
  • Greenlight Guru
  • MasterControl
  • SAP R/3
  • Microsoft Dynamics NAV
  • R 


Medical Devices:

  • Measuring devices (bioimpedance and vital parameters)
  • Dialysis machines and accessories
  • Ventilators
  • Sterilizers + Washer-Disinfectors
  • Face masks + Disinfecting agents
  • SaMD with AI
  • Hydrocephalus shunt systems 


Professional Knowledge (Regulations and standards):

  • MDR (EU) 2017/745
  • EN ISO 13485
  • EN ISO 14971 (Risk Management)
  • EN 62304
  • EN 60601-1
  • 21 CFR Part 820 (USA)
  • ASEAN Medical Device Directive (APAC)
  • MHLW Ministerial Ordinance No. 169 (Japan)
  • Therapeutic Goods Act (Australian) 


Risk Management:

  • ISO 14971 process ownership
  • FMEA
  • risk-benefit analysis
  • device-specific risk analyses
  • integration of risk management into design control 


Soft Skills:

  • Leadership
  • Communication
  • Creative solutions
  • Problem-solving
  • Pragmatism 

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

5 Monate
2026-04 - heute

Conduct ISO 14971 risk analyses

Independent Consultant
Independent Consultant
  • Conduct ISO 14971 risk analyses and usability file reviews for active medical devices in ENT diagnostics, ensuring regulatory compliance and audit readiness 
Self-Employed
1 Jahr 3 Monate
2025-06 - heute

Responsible for the development of an electronic measuring neuro-implant

Director Software & Electronics Development
Director Software & Electronics Development
  • Lead 3 cross-functional teams (17 members) spanning app development, embedded software, and electronics engineering 
  • Responsible for the development of an electronic measuring neuro-implant with wearable and app integration, achieving CE certification and advancing FDA De Novo submission 
  • Responsible for integrating ISO 14971 risk management into design control across the teams, including FMEA and residual risk evaluation ahead of CE certification 
  • Lead a funded R&D initiative for a smart neuro-implant to treat hydrocephalus 
  • Lead organization-wide rollout of a data-driven electronic quality management system (e-QMS), currently in implementation 
Christoph Miethke GmbH, Potsdam
1 Jahr 8 Monate
2023-10 - 2025-05

Responsible for ISO 14971 risk management support

Director Projektmanagement, Quality & Regulatory
Director Projektmanagement, Quality & Regulatory
  • Manage two teams ? Project Management and Quality & Regulatory ? totaling 8 employees 
  • Serve as Project Manager for the development of a Class IIA active, cloud-connected measuring device with a team of 30+, leading registrations in the EU, US, and China and securing successful 510(k) clearance 
  • Act as Management Representative for a TÜV SÜD-certified ISO 13485 QMS (Scope: Design and Development), achieving zero findings in an audit 
  • Responsible for ISO 14971 risk management support across client projects, ensuring risk-based decision-making in design and development 
D.med Consulting, Hamburg
10 Monate
2023-01 - 2023-10

Support ISO 14971 risk management considerations

Head of Quality & Regulatory
Head of Quality & Regulatory
  • Manage the Quality & Regulatory team of 3 employees 
  • Serve as Project Manager for the development of a Class IIA active, cloud-connected measuring device with a team of 30+, leading registrations in the EU, US, and China 
  • Support market access strategies and MDR gap analyses for QMS and technical documentation across multiple medical devices and client portfolios 
  • Support ISO 14971 risk management considerations as part of MDR gap analyses and technical documentation reviews 
  • Act as Management Representative for a TÜV SÜD-certified ISO 13485 QMS (Scope: Design and Development) 
D.med Consulting, Hamburg
2 Jahre 8 Monate
2020-05 - 2022-12

Ensured Quality Assurance for dialysis machine manufacturers

Quality Assurance and Regulatory Affairs Manager
Quality Assurance and Regulatory Affairs Manager
  • Ensured Quality Assurance for dialysis machine manufacturers, by achieving compliance and audit readiness 
  • Optimize engineering systems for design & development processes, tools, and methods, improving efficiency and traceability for client organizations 
  • Provide strategic consulting and deputy project management on regulatory requirements in the Asia-Pacific region, enabling clients to navigate complex multi-market approval pathways 
  • Advise dialysis machine manufacturers on ISO 14971 risk management processes, ensuring risk controls are documented and verified prior to regulatory submission 
  • Conduct design verification of a ventilator, including verification of risk control measures, supporting successful regulatory submission 
  • Develop market access strategy for a non-active medical device, accelerating time-to-market for the client 
  • Support business development, sales, and marketing initiatives, contributing to client acquisition and portfolio growth 
qtec Services GmbH, Remote
2 Jahre 1 Monat
2018-04 - 2020-04

Create, review, and update technical documentation in STED format

Quality and Regulatory Affairs Manager
Quality and Regulatory Affairs Manager
  • Implement and maintain a full ISO 13485 QMS for the world market leader in practice hygiene and sterilization technology 
  • Establish and maintain the ISO 14971 risk management process as a core component of the QMS, ensuring risk management files support global product registrations 
  • Lead international product registrations in Japan, Australia, China, Russia, Singapore, and beyond, covering both active and non-active medical devices, supporting the company's global export footprint across 80+ countries 
  • Manage audits (e.g., EN ISO 13485, MDD, PED, KGMP, LAGeSo inspection) 
  • Create, review, and update technical documentation in STED format 
MELAG Medizintechnik, Berlin
5 Monate
2017-11 - 2018-03

Assist with preparation and follow-up of internal and external audits

Working Student - Quality management
Working Student - Quality management
  • Support the Quality Management department in maintaining ISO 13485 documentation 
  • Support maintenance of risk management documentation under ISO 14971 
  • Assist with preparation and follow-up of internal and external audits 
  • Contribute to the review and update of technical documentation 
  • Support daily QM processes and administrative tasks within the department 
MELAG Medizintechnik, Berlin
8 Monate
2017-02 - 2017-09

Develop and program a software application

Master Thesis
Master Thesis
  • Master's thesis: "on request" 
  • Develop and program a software application to support dialogue-based quality methods in incoming goods inspection 
  • Perform software validation and successfully introduce the application into company use 
  • Collaborate with cross-functional stakeholders to design and validate the approach for process improvement 
Philips Medical Systems, Hamburg
6 Monate
2016-08 - 2017-01

Support the Operations Quality department

Intern
Intern
  • Support the Operations Quality department in the production of X-ray and CT tubes 
  • Assist with quality control and inspection processes during manufacturing 
  • Contribute to documentation and compliance activities within a regulated production environment
Philips Medical Systems, Hamburg
11 Monate
2015-09 - 2016-07

Support process and document management

Working Student - Process and Document Management
Working Student - Process and Document Management
  • Support process and document management using the Method Park Stages tool 
  • Assist in modeling, documenting, and maintaining organizational processes 
  • Contribute to process compliance and continuous improvement initiatives 
IAV, Berlin

Aus- und Weiterbildung

Aus- und Weiterbildung

06/2008

Abitur

Johann-Rist-Gymnasium, Wedel


09/2015

Bachelor of Science Industrial Engineering and Management

Technical University Berlin

Specialization in Mechanical Engineering


03/2018

Master of Science Industrial Engineering and Management

Technical University Berlin

Specialization in Biomedical Technology


CERTIFICATIONS

  • ISTQB Certified Tester - Foundation Level
  • DGQ Quality Systems Manager Junior
  • Six Sigma Green Belt
  • Risk Management Training
  • Lean Management Training
  • DIN Standardization Expert Module 1 (Principles of Standardization)

Kompetenzen

Kompetenzen

Top-Skills

ISO 14971 Risikomanagement ISO 13485 QMS MDR (EU) 2017/745 Design Control EN 62304 EN 60601-1 FDA 21 CFR Part 820 Audits (interne & externe) Technische Dokumentation Usability Engineering (IEC 62366) Projektmanagement Medizinprodukte

Produkte / Standards / Erfahrungen / Methoden

SUMMARY

  • Quality, Regulatory & Project Management professional with 10+ years of experience in the medical device industry, spanning active implantable devices, dialysis systems, ventilators, and sterilization technology. Experience leading cross-functional teams and supporting international product registrations (EU, US, China, Japan, and beyond), CE certifications, and ISO 13485 QMS implementation. Combines technical and regulatory expertise with project leadership to support compliant, market-ready medical devices from concept to launch. 
  • Risk management is a core element of medical device development and has been a consistent focus throughout my career ? from establishing ISO 14971 risk management processes within QMS frameworks to independently preparing device-specific risk analyses supporting design control and regulatory submissions. 


SKILLS

IT:

  • Microsoft Office (Teams, Word, Excel, PowerPoint, Project, Visio)
  • Asana
  • MatrixReq
  • PTC Windchill
  • Siemens Polarion
  • Enterprise Architect
  • Method Park Stages
  • Greenlight Guru
  • MasterControl
  • SAP R/3
  • Microsoft Dynamics NAV
  • R 


Medical Devices:

  • Measuring devices (bioimpedance and vital parameters)
  • Dialysis machines and accessories
  • Ventilators
  • Sterilizers + Washer-Disinfectors
  • Face masks + Disinfecting agents
  • SaMD with AI
  • Hydrocephalus shunt systems 


Professional Knowledge (Regulations and standards):

  • MDR (EU) 2017/745
  • EN ISO 13485
  • EN ISO 14971 (Risk Management)
  • EN 62304
  • EN 60601-1
  • 21 CFR Part 820 (USA)
  • ASEAN Medical Device Directive (APAC)
  • MHLW Ministerial Ordinance No. 169 (Japan)
  • Therapeutic Goods Act (Australian) 


Risk Management:

  • ISO 14971 process ownership
  • FMEA
  • risk-benefit analysis
  • device-specific risk analyses
  • integration of risk management into design control 


Soft Skills:

  • Leadership
  • Communication
  • Creative solutions
  • Problem-solving
  • Pragmatism 

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