freiberufler Interim Manager, Medtech-, Strategy- & IT-Consultant auf freelance.de

Interim Manager, Medtech-, Strategy- & IT-Consultant

offline
  • 110‐125€/Stunde
  • 60435 Frankfurt am Main
  • Europa
  • de  |  en
  • 08.08.2024

Kurzvorstellung

- medical product engineering and realization of go-to-market strategies
- 20+ years of leadership experience
- success-driven attitude and hands-on mentality
- technical and commercial expertise
- MBA with broad additional qualifications

Qualifikationen

  • Agile Methodologie20 J.
  • DIN EN ISO 134851 J.
  • Finanzielle Planung30 J.
  • international contracts
  • international negotiations
  • leadership experience (> 20 years, < 180 FTE)
  • Personalplanung18 J.
  • Programm-Management18 J.
  • Projektmanagement30 J.
  • regulatory management MDR
  • Scrum20 J.
  • Strategische Unternehmensplanung30 J.

Projekt‐ & Berufserfahrung

Section Manager EMEA Item Master Medical Products MDR Olympus SE (Interim Manager)
Olympus SE, Hamburg
7/2023 – 12/2023 (6 Monate)
Gesundheitswesen
Tätigkeitszeitraum

7/2023 – 12/2023

Tätigkeitsbeschreibung

- Verantwortlich für die Sicherstellung der Datenqualität von ca. 100.000 medizinischen Gerätedatensätze in SAP in der EMEA-Region.
- Führung und disziplinarische Verantwortung für 15 Mitarbeiter, aufgeteilt auf zwei Teams und ein gemeinsames Servicezentrum in zwei verschiedenen Ländern.
- Übernahme der fachübergreifenden Zuständigkeit für die regulatorische und kommerzielle Datenqualität medizinischer Produkte in der EMEA-Region, einschließlich der Rolle als Business Solution Architekt u.a. für die Prozesse der Eindeutigen Geräteidentifikation (UDI) und der Globalen Handelsartikelnummer (GTIN).
- Zuständig für die Erstellung neuer Datensätze für medizinische Produkte als Prozessverantwortlicher
- Untestützung des globalen Stammdaten-Governance-System, speziell für regulatorische und Qualitätsdaten von medizinischen Produkten.

Eingesetzte Qualifikationen

SAP ECC

Head of Project Management (DACH, Interim Manager)
Getinge, Rastatt
7/2022 – 6/2023 (1 Jahr)
Medical Engineering
Tätigkeitszeitraum

7/2022 – 6/2023

Tätigkeitsbeschreibung

- responsible for 30 Mio € installations of medical devices in operation room, ICU and hospital infrastructure
- functional authority for 20 FTE
- cross-functional lead of additional 10 FTE
- responsible for pre & post calculation of all regional installation projects
- direct customer contact responsible
- legal authority for supplier orders and customer quotes
- Supplier management of appr. 70 suppliers
- regulatory responsibility of compliant installation according to instruction for use in
- responsible for contract management with suppliers & customers

Eingesetzte Qualifikationen

Finanzielle Planung, Projektmanagement, Regulatory Affairs, Supplier Relationship Management (SRM), Vertragsmanagement

CEO class 3 MedTech company (Interim Manager)
Smartcanula LLC, Lausanne
4/2022 – 1/2023 (10 Monate)
Health Care
Tätigkeitszeitraum

4/2022 – 1/2023

Tätigkeitsbeschreibung

- responsible for MDR & FDA submission program
- Chairman of the board
- Head of Quality – full ISO 13485 QMS
- Head of Regulatory
- Head of Finance
- successful QMS audit ISO 13485 with DEKRA NL as notified body with only one minor deviation
- successful handover to main investor as new CEO according to business plan

Eingesetzte Qualifikationen

DIN EN ISO 13485, Finanzielle Planung, Programm-Management, Qualitätsmanagement (allg.), Regulatory Affairs, Strategische Unternehmensplanung

Workstream Lead Class 3 MDR Submission Neuro / Spine Surgical Instruments (Interim Manager)
Karl Storz, Tuttlingen
11/2021 – 9/2022 (11 Monate)
Medical Engineering
Tätigkeitszeitraum

11/2021 – 9/2022

Tätigkeitsbeschreibung

- responsible for MDR Submission Program
- member of the Steering Committee as Program Manager of a strategic initiative
- functional authority for 120 FTE
- cross-functional lead of ~12 subprojects
- preparation and group lead negotiations with notified body
- lead of cross-functional definition of intended use descriptions
- tracking and auditing R&D development process based on V-model, verification & validation, sterilization process, BioCompatibility Testing
- implementation of aggregated and detailed Project in MS Project
- responsible for Resource Management according to chapter 6 EN DIN ISO 13485
- MDR Expert

Eingesetzte Qualifikationen

DIN EN ISO 13485, Forschung & Entwicklung, Programm-Management, Projektmanagement, Regulatory Affairs, Strategische Unternehmensplanung, Vertragsmanagement

Head of Product Centre Heart Therapies icor – synchronized cardiac support pulsatile VA ECMO (ECLS)
Xenios AG, Heilbronn
1/2019 – 8/2021 (2 Jahre, 8 Monate)
Health Care
Tätigkeitszeitraum

1/2019 – 8/2021

Tätigkeitsbeschreibung

- responsible for disciplinary & cross functional activities development of worldwide new pulsatile VA ECMO
- member of the management team
- responsible for product center budget (> 5 Mio €)
- disciplinary authority for 12 FTE
- program-manager R&D projects
- hard & software development incl. bench testing
- process owner internal & external training for clinical professionals
- responsible for in-center clinical support
- owner of therapy life cycle process icor
- resource owner product innovation icor program
- coordinator icor sales / marketing projects
- implementation of scrum into the icor program
- generation of IP (2 technical innovations, 2 patents)

Eingesetzte Qualifikationen

Agile Methodologie, Analyse der Markt- / Wettbewerbsposition, Einkaufsverhandlungen, Entscheidungsprozessmanagement, Finanzielle Planung, Forschung & Entwicklung, Programm-Management, Scrum, Strategisches Management, Vertragsmanagement

Head of Project Management for R&D and Organization (Interim Manager)
Xenios AG, Heilbronn
1/2018 – 12/2018 (1 Jahr)
Health Care
Tätigkeitszeitraum

1/2018 – 12/2018

Tätigkeitsbeschreibung

- responsible for introduction of project management processes in R&D
- Operations, Sales & Marketing, functional authority for all project managers >150 FTE
- project manager master data management / FMC go-life of all Xenios products in SAP sales
- implementation of project management tools Planview and Projectplace
- process owner of SOP project management & overall resource management

Eingesetzte Qualifikationen

Agile Methodologie, Analyse der Markt- / Wettbewerbsposition, Entscheidungsprozessmanagement, Forschung & Entwicklung, Kompetenzmanagement, Personalentwicklung, Projektmanagement, Scrum

General Manager/CEO
[...] GmbH, Frankfurt am Main
4/2006 – offen (18 Jahre, 9 Monate)
Management Consulting
Tätigkeitszeitraum

4/2006 – offen

Tätigkeitsbeschreibung

General Manager/CEO
- responsible for P&L
- disciplinary authority for up to 15 FTE
- responsible for the overall business success of the diverse projects with customers
- identifying strategic business opportunities for clients and their own company as solutions for complex technical requirements or strategic market opportunities

Medtech Consulting
- providing Market Data & Reimbursement Consulting
- Medical Product Engineering
- development of go-to-market strategies

Strategy Consulting and Interim Management Projects
- analysis of business performance, development of business strategies and KPI Systems giving direction to the management on how to lead business units to success (often in combination with taking part time or interim responsibility for project teams or departments, along with outsourcing certain processes)

IT Consulting
- technical innovations in multidimensional database and development of graphical user interfaces for management information systems with SAP, MS-Navision, IBM, Oracle, Microsoft SQL/BI, master data management projects

Eingesetzte Qualifikationen

Agile Methodologie, Finanzielle Planung, Personalplanung, Programm-Management, Projektmanagement, Scrum, Strategische Unternehmensplanung

Head of Category Management & Project Manager Due Diligence Supply Chain (Interim Manager)
SMS Plastics Technology Group, Meinerzhagen
3/2004 – 3/2006 (2 Jahre, 1 Monat)
Plastics
Tätigkeitszeitraum

3/2004 – 3/2006

Tätigkeitsbeschreibung

- functional authority 15 FTE for 12 companies in the corporate group and 25 million euro spend
- due diligence for supply chain of all 12 companies in preparation for selling the group

Eingesetzte Qualifikationen

Einkaufsverhandlungen, Finanzielle Planung, Projektmanagement, Strategische Unternehmensplanung, Supplier Relationship Management (SRM), Vertragsmanagement

Project Manager for E-Commerce and Supply Chain Controlling (Interim Manager)
MAN Holding and MAN Group international, Frankfurt am Main
1/2002 – 2/2004 (2 Jahre, 2 Monate)
Office devices (faxes, copiers, printers, scanners, etc.)
Tätigkeitszeitraum

1/2002 – 2/2004

Tätigkeitsbeschreibung

- strategy development e-commerce MAN Group wide
- technical and operational leadership of data integration of all spend data for MAN companies in one data warehouse
- introduction of category management in the MAN Group
- technical development of a management information system & change management to implement operational controls & procedures

Eingesetzte Qualifikationen

Agile Methodologie, Analyse der Markt- / Wettbewerbsposition, Digitalisierung, Einkaufsverhandlungen, Entscheidungsprozessmanagement, Finanzielle Planung, Projektmanagement, Prozessmanagement, Scrum, Strategische Unternehmensplanung, Supplier Relationship Management (SRM), Vertragsmanagement, Vertragsrecht, Wettbewerbsanalyse

Head of Planning and Controlling
MAN Roland Druckmaschinen, Frankfurt am Main
1/1999 – 12/2001 (3 Jahre)
Office devices (faxes, copiers, printers, scanners, etc.)
Tätigkeitszeitraum

1/1999 – 12/2001

Tätigkeitsbeschreibung

- responsible for spend and material planning & controlling for 4 plants
- disciplinary authority for 3 FTE and 40 million euro spend as controller
- accountable for development of e-commerce strategy for the MAN Group
- team leader of cross-functional strategy development team

Eingesetzte Qualifikationen

Analyse der Markt- / Wettbewerbsposition, Digitalisierung, Entscheidungsprozessmanagement, Finanzielle Planung, Forschung & Entwicklung, Projektmanagement, Prozessmanagement, Strategische Unternehmensplanung, Wettbewerbsanalyse

Head of Category Management for IT & Facility Management
Schott Glas & Carl Zeiss, Mainz
1/1997 – 12/1999 (3 Jahre)
Packaging: Glass
Tätigkeitszeitraum

1/1997 – 12/1999

Tätigkeitsbeschreibung

- functional authority 20 FTE for 35 companies in the corporate group and 70 million euro spend

Eingesetzte Qualifikationen

Analyse der Markt- / Wettbewerbsposition, Digitalisierung, Entscheidungsprozessmanagement, Finanzielle Planung, Kompetenzmanagement, Personalentwicklung, Projektmanagement, Prozessmanagement, Strategische Unternehmensplanung, Wettbewerbsanalyse

Head of Technical Purchasing
Schott Glas, Mainz
1/1995 – 12/1999 (5 Jahre)
Packaging: Glass
Tätigkeitszeitraum

1/1995 – 12/1999

Tätigkeitsbeschreibung

- disciplinary authority for 12 FTE and 20 m EUR spend

Eingesetzte Qualifikationen

Analyse der Markt- / Wettbewerbsposition, Digitalisierung, Einkaufsverhandlungen, Finanzielle Planung, Projektmanagement, Prozessmanagement, Strategische Unternehmensplanung, Vertragsmanagement, Wettbewerbsanalyse

Zertifikate

Medical Device Consultant Olympus
2023

Ausbildung

Medical device consultant (Getinge Deutschland GmbH)
Ausbildung
2022
Raststatt
Medical device consultant (Xenios AG)
Ausbildung
2020
Frankfurt am Main
Scrum Master with focus on design-controlled R&D projects
Ausbildung
2019
Frankfurt am Main
Cognitive Behavioral Therapist (German approval for psychotherapy)
Ausbildung
2015
Frankfurt am Main
Systemic Coach
Ausbildung
2015
Frankfurt am Main
Strategic Management & Finance (job integrated part time)
Master of Business Administration
2000
University of Bradford, United Kingdom
Enterprise Management & Business Computer Science (job integrated part time)
Degree as Business Economist
1999
Mainz University of Applied Sciences
Specialist Purchasing & Materials Management
Ausbildung
1995
Frankfurt am Main
Industrial Clerk
Ausbildung
1994
IHK Mainz

Über mich

I will bring your innovative medical products successfully into the market!

Successes
- Building up the first CE pulsatile VA ECMO from a question mark to a strategic initiative of the company and proofing safety & efficacy in two clinical studies
- Development of a secure ECG algorithm for pacer blanking to ensure pulsatile
VA ECMO treatment for 100 percent of the patient population with pacemakers
(Prior to this no treatment for pacer patients, representing 50 percent of the market, was possible) incl. two patents on the algorithm and technical bench test architecture
- Development of a KI based medical market intelligence database to combine market data with clinical studies, reimbursement data from INEK and hospitals
- Successful completion of a due diligence process for the acquisition of a class 3 MedTech company as investor & responsibility as CEO, Head of Quality & Head of Regulatory in the first phase of the investment (incl. successful DEKRA Audit)

Weitere Kenntnisse

Areas of competence
- Corporate strategy and planning with focus on profitability
- Budgeting and business case management
- International program & project manager
- Interim mandates with three global MedTech market leaders
- Product Owner Research & Development, product engineering in medical technology & design control processes
- Expert on regulatory requirements for medical devices (especially Medical Device Regulation, DIN/ISO 13485 and DIN/ISO 14971)
- Design and realization of medical studies and management of medical study hospitals (physicians & study nurses)
- Sales & certified trainings of medical products and related medical content to physicians, perfusionists & hospital administration
- Medical device consultant (certified consultant for medical devices based on German law in two global acting MedTech companies)
- Medical presentations and management of booths on international medical congresses
- Comprehensive knowledge of business processes and standards
- Design and implementation of value chains
- Organizational development and competence management
- Expertise as CEO in a MedTech startup
- Negotiation skills in procurement, sales & legal contracts (practicable and theoretical)

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
298
Alter
52
Berufserfahrung
30 Jahre und 4 Monate (seit 08/1994)
Projektleitung
20 Jahre

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