Consulting & RAQ-Service.

Based on my high competence and experience in the areas of Regulatory Affairs, Quality Management and General Management (including trainings and workshops), my service covers a wide range in the IVD-Medical Device-sector. My focus is exclusively on the needs of my clients.

Please visit my service area or contact me directly for further information.

About Me

Short Vita.

As a Medical Technician and subject-matter expert for Biotechnology, I could acquire my technical Know-how over 16 years in Research and Development in Microbiology, Protein Analysis, Immunology, Integrated Cancer Care and Molecular Biology in both, Pharma and Diagnostics divisions of Boehringer Mannheim/Roche with being familiar with all corresponding procedures, methods and technics.

After this I extended my management skills based on university degrees in Health Economics (BA) and Health Management (MaHM), as well as on different multinational and interdisciplinary leadership roles in line- and matrix- organizations, mainly in the area of Regulatory Affairs (RA) and Quality Management (QM) but in Interface Management with Business Development, Marketing, Finance, Clinical Affairs and Manufacturing in well-known Pharma and MedTech companies as well. In addition this included tools and instruments for personnel management and resource planning, but also effective and efficient communication across all hierarchy levels.

In 2023, after 20 years being responsible for global RA for IVDs (16 y) and drugs (4 y) covering RA strategy, registrations and submissions with authorities through market access in compliance with all regulatory requirements including QM, I decided to start my own consulting business to provide RAQ-Management Service.

Jahre

RnD Lab Experience.

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Jahre

Global RA/QM IVDs.

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Jahre

Global RA/drugs.

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Jahre

Mgmt. skills.

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Services

Regulatory Affairs. Quality Management. General Management.

Regulatory Affairs

RA strategy from design through market access globally.

Defining a product specific RA strategy globally to assure an efficient submission and registration process of the products with local authorities to reduce the time to market.
Review of the product specific technical documentation to assure completeness of the content and compliance with the regulatory requirements by gap analysis or adaption of the reports.
Determine the impact of the differences between the IVD-Regulation compared to the former IVD-Directive (for EU member states) to keep the technical documentation up-to-date.
Assisting in interactions with competent authorities or Notified Bodies by leading and coordinating related meetings, design examinations or audits.
Support in establishing clinical evidence, performance evaluation and performance studies with sponsors or investigators and review of related documentation.
Identifying and evaluating regulatory consultants/experts in countries (where required) to have a local organization or affiliate as interface with the country specific competent authorities.

Quality Management

Incl. Audit- & Risk-Management.

Defining a company specific Quality Management System (QMS), e.g. acc. to ISO 13485 or 9001 or related to customer needs.
Assisting in optimization of processes to assure that the QMS is effective and efficient and will be kept up-to-date regarding regulatory requirements.
Support in inspections and Audit-Management internally (across the different functions within the company) and externally (with Notified Bodies, customers, or suppliers)
Assist in establishing a Risk Management System to consider regulatory compliance and to assure that the product is safe (for user and patient), effective and has the right quality regarding its intended purpose.

General Management

Incl. Workshop & Trainings.

Assist in resource mgmt. & organizational dev. to assure that the organization/departments are set up acc. to their competencies.
Assist in defining employee dev. plans acc. to their experiences & competencies.
Support in workload prioritization to allow efficient decision making.
Coaching of employees and dev. of tools in areas of conflict mgmt., communication & leadership skills.
Trainings and workshops with focus on:
- Essentials for IVD products acc. to IVDR requirements in cooperation with Forum Management (e.g., classification, differentiation of IVD compared to medical devices or drugs, Near Patient Testing, labeling, UDI (Unique Device identification) requirements, performance evaluation, technical documentation etc.)
- Environmental requirements (e.g., RoHS (Restriction of Hazardous Substances), REACH (Registration, Evaluation, Authorization of Chemicals), CLP (Classification, labeling and Packaging), Circular Economy, etc.)
- Supplier Mgmt. (e.g., Supplier Audits, "Lieferkettensorgfaltspflichtengesetz")

YOUR key

to success.

KARIN LISTRINGHAUS
Consulting & RAQ-Service
Mühldelle 8 | 64646 D-Heppenheim

Tel +49 (0)175 4146 381
mail@listringhaus-consulting.com

SPEAKER AT

Forum • Institut für Management GmbH