Senior Medical Device Consultant & Digital Transformation Expert

1/2025 – 12/2025

• Overall Project Management for critical Design Change in Product Families
o Project team of 60+ Persons
o Interdisciplinary and international team
o Three Product series with various Variants including country-
specific solutions
• Resource and budget planning for Whole Project
• Integration Planning
o Synchronization between projects
o multiple Device Project Managers and Product Managers
• Define and manage Product- and Project Requirements
• Organize risk management approach on component change for device family
o Ensuring match of Bootom-Up and Top-Down Approach
o Synchronization with HW- , SW- and Risk Management Team
• Regular Reporting to Upper Management
• Review and suggestions for Polarion usage for product, development and
variant management

Achievements
• Overall Project plan and integration planning for next 3 years of development
• Re-Structured Resource and Budget planning for the project lifecycle
• Clear sprint and release plannings for Business unit covering multiple Product
Releases
• Clarified Prioritization and task synchronization
• Complete Approach on Requiremenents and Risk management for component
change
• Defined integration timelines including software integration and releases

Kundenberater

2/2024 – 11/2024

Responsibilities • Preparation of Audit Readiness for Franchising companies

o FDA, external and internal audits
• Supporting hands-on in implementing Teams
o CAPA Implementation
o Gemba Walks
o Regular Production reviews
o Deep Dive Teams
o Working with site managers to develop compliant solutions
o Review and Organoze Risk based Approach
o Test method- and process validations, sample planning
• Reporting to Director of Compliance
o Overview of current status
o Suggestions for improvements
Achievements • Closing all CAPA activities within FDA time-limits
• Identifying, analyzing and tracking deviations
• Support in preparing one multi-site franchise company for FDA; internal audits,
notified body audit and authoritiy audits

Regulatory Affairs Manager

5/2014 – offen

Technische Dokumentation
IEC 60601-1 update (3rd ed)
Entwicklungs-, Risikomanagement-, Usability-Prozesse

Medizintechnik, Technische Dokumentation, Risikomanagement, Forschung & Entwicklung