SANDRA WENIGER-NIEDERBERGER
The powerful mentor
"If you want to build a ship, don't drum up people to collect wood and don't assign them tasks and work, but rather teach them to long for the endless immensity of the sea."
Antoine de Saint-Exupéry, The Wisdom of the Sands, Citadelle (1948)
The Life Sciences ecosystem enables great things. It can heal, make life easier, or detect serious diseases at early stages — in every phase of a human life.
However, this perspective is often forgotten in concrete implementation projects. We are too far removed from the actual purpose. My intention is to remind us of the meaning behind our actions and regulations — and also to question them — so that therapies, medicines, and medical devices can be approved and monitored quickly and effectively.
To define the HOW, the WHY must be understood. It always inspires me to lead specialists and young talents in line and project roles to sustainable success through this people-oriented approach.
SANDRA WENIGER-NIEDERBERGER
The powerful mentor
"If you want to build a ship, don't drum up people to collect wood and don't assign them tasks and work, but rather teach them to long for the endless immensity of the sea."
Antoine de Saint-Exupéry, The Wisdom of the Sands, Citadelle (1948)
The Life Sciences ecosystem enables great things. It can heal, make life easier, or detect serious diseases at early stages — in every phase of a human life.
However, this perspective is often forgotten in concrete implementation projects. We are too far removed from the actual purpose. My intention is to remind us of the meaning behind our actions and regulations — and also to question them — so that therapies, medicines, and medical devices can be approved and monitored quickly and effectively.
To define the HOW, the WHY must be understood. It always inspires me to lead specialists and young talents in line and project roles to sustainable success through this people-oriented approach.
BACKGROUND
As a passionate compliance expert and consultant with a degree in Business Informatics and a CAS in "Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics", I have more than 20 years of experience in the pharmaceutical and medical device industry. I have led numerous national and international projects and possess broad compliance expertise with perspectives from various frameworks. These experiences enable me to develop individual solutions with my clients — whether for international corporations or for SMEs and startups. As a project manager, mentor, or subject matter expert, I can act as a catalyst especially at the intersection of business, IT, quality management, and regulatory affairs to deliver significant added value and help shape the digital direction.
CONSULTANCY FOCUS
Interpret regulatory requirements and implement them
in processes, systems, and organizational structures based on risk
Empower people through coaching and consulting on compliance topicsLink compliance with digital transformation projects
Use cases in Quality Management, Regulatory Affairs,
Ethics and Compliance, IT, GxP, MDR, IVDR, ISO, and CSV
BACKGROUND
As a passionate compliance expert and consultant with a degree in Business Informatics and a CAS in "Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics", I have more than 17 years of experience in the pharmaceutical and medical device industry. I have led numerous national and international projects and possess broad compliance expertise with perspectives from various frameworks. These experiences enable me to develop individual solutions with my clients — whether for international corporations or for SMEs and startups. As a project manager, mentor, or subject matter expert, I can act as a catalyst especially at the intersection of business, IT, quality management, and regulatory affairs to deliver significant added value and help shape the digital direction.
CONSULTANCY FOCUS
Interpret regulatory requirements
and implement them in processes,
systems, and organizational structures based on risk
Empower people through coaching and consultingon compliance topics
Link compliance with digitaltransformation projects
Use cases inQuality Management, Regulatory Affairs,
Ethics and Compliance, IT, GxP, MDR, IVDR,
ISO, and CSV
LIGHTHOUSE PROJECTS
Ensuring IT quality in the transformation to digital processes
During the merger of a global medical device manufacturer, I supported the local logistics center in ensuring regulatory IT quality during the transition from manual to digital processes in product labeling, warehouse management, cold chain processes, delivery error management, and quality controls aligned with country-specific registration information. I was responsible for compliance with applicable EU, FDA, and company-specific requirements by developing software validation strategies, feasibility assessments, and designs of strategic application landscapes with a focus on GxP-critical records and their data integrity.
Analysis for achieving medical market authorization as a digital health application
For a software as a medical device, I conducted an analysis of the regulatory requirements to prepare for German market access as a digital health application (DiGA) according to the BfArM Fast Track approach. I was responsible for analyzing regulatory requirements including data protection, information security, clinical trials, safety, functionality, and quality aspects, the documentary gap analysis between MDD/MDR/DiGA legislation, and the development of an approach for the clinical evidence assessment of the medical app.
Quality manager for an ISO 9001 quality management system
As quality manager of a consulting company, I was responsible for the supervision and improvement of the quality management system for 9 years. During this time, I successfully passed large and medium customer-supplier audits with a focus on GxP, ISO 9001/13485, value-added processes, IT security, employee training, and quality controls. I coached and advised internal functions on business process analysis and modeling, and developed and delivered quality management/CSV training and workshops.
LIGHTHOUSE PROJECTS
Ensuring IT quality in the transformation to digital processes
During the merger of a global medical device manufacturer, I supported the local logistics center in ensuring regulatory IT quality during the transition from manual to digital processes in product labeling, warehouse management, cold chain processes, delivery error management, and quality controls aligned with country-specific registration information. I was responsible for compliance with applicable EU, FDA, and company-specific requirements by developing software validation strategies, feasibility assessments, and designs of strategic application landscapes with a focus on GxP-critical records and their data integrity.
Analysis for achieving medical market authorization as a digital health application
For a software as a medical device, I conducted an analysis of the regulatory requirements to prepare for German market access as a digital health application (DiGA) according to the BfArM Fast Track approach. I was responsible for analyzing regulatory requirements including data protection, information security, clinical trials, safety, functionality, and quality aspects, the documentary gap analysis between MDD/MDR/DiGA legislation, and the development of an approach for the clinical evidence assessment of the medical app.
Quality manager for an ISO 9001 quality management system
As quality manager of a consulting company, I was responsible for the supervision and improvement of the quality management system for 9 years. During this time, I successfully passed large and medium customer-supplier audits with a focus on GxP, ISO 9001/13485, value-added processes, IT security, employee training, and quality controls. I coached and advised internal functions on business process analysis and modeling, and developed and delivered quality management/CSV training and workshops.