Medical Affairs, Regulatory Affairs, ISO 13485, MDSAP, QM-Doku, Techn. Doku, CAPA, Risk-Management, Audits

8/2021 – 3/2022

• Participate in preparatory training (CIP, SOP, product, eCRF).
• Conduct and document educational and consent discussions for subjects (remotely).
• Processing of SAEs
• Collaboration on monitor visits
• Collaboration on query processing
• Preparation prior to inspections
• Supervision of study nurses
• Participation in TCs with the study center or sponsor

Clinical Study Manager

7/2021 – 6/2022

• Regulatory Affairs consulting

Regulatory Affairs

7/2020 – 12/2023

• Local Project Management of MDR Remediation
• Implementation of the results of a completed gap analysis of the technical documentation / DHF for class IIb / III medical devices
• make additions and changes to the documentation / creation of summary documents
• Support in the generation of new documents based on measurements that need to be initiated and maintained.
• Coordination with departments involved in the documentation
• Ensuring documentation compliance in accordance with MDR and 21 CFR 820
• Storage of the documentation in a PLM system
• Directing documentation to relevant departments
• Support for the transition from paper-based to electronic documentation using the PLM system Teamcenter Unified (TCU)
• Support in communication
• Support in change management with Trackwise 8
• Assisting with the creation of documents as part of adapting to a new Baxter internal risk management procedure

Interim Management, Qualitätsmanagement (allg.), Regulatory Affairs

4/2019 – 6/2020

• Implementation of the results of a completed gap analysis of the technical documentation / DHF for class IIb / III medical devices
• make additions and changes to the documentation / creation of summary documents
• Support in the generation of new documents based on measurements that need to be initiated and maintained.
• Coordination with departments involved in the documentation
• Ensuring documentation compliance in accordance with MDR and 21 CFR 820
• Storage of the documentation in a PLM system
• Directing documentation to relevant departments
• Support for the transition from paper-based to electronic documentation using the PLM system Teamcenter Unified (TCU)
• Support in communication
• Support in change management with Trackwise 8
• Assisting with the creation of documents as part of adapting to a new Baxter internal risk management procedure

Qualitätsmanagement (allg.), Regulatory Affairs

2/2019 – 8/2019

• Generate Clinical Evaluation Reports
• Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary

Medizin, Medical Writing, Regulatory Affairs

7/2018 – 12/2018

• Creation, update and maintenance of technical documentation / design dossiers / STED files in the area of hospital products
• Document Management of the RA Documentation
• Change Control
• Contact to Notified Bodies (TÜV Süd, BSI)
• MDR GAP analysis
• MDR certification strategy development

Market Access, Regulatory Affairs

4/2018 – 12/2018

• MDR GAP Analysis of the technical documentation and derivation of corresponding tasks

Regulatory Affairs

4/2017 – 3/2018

Personal responsibility for 4 employees

• Leadership and development of Regulatory Clinical Affairs department and its employees
• Define regulatory needs regarding clinical safety and clinical performance for the product portfolio of the HARTMANN group (full spectrum of Medical Devices from class I to class III, active and non-active Medial Devices)
• Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary
• Support for product registration, market access, risk analysis, post-marketing reviews
• Strategical and conceptional development of department
• Generate Clinical Evaluation Reports
• Execution, communication and reporting of feasibility, CE mark and post-marketing clinical investigations to enable the company to meet its business objectives
• Planning, organization, implementation and evaluation of clinical trials including coordination of external service providers (CROs)
• Support country organizations with clinical evaluations

Clinical Study Manager, Qualitätsmanagement (allg.), Regulatory Affairs

4/2016 – 3/2017

Preparation of registration documents for the products of the Hartmann Group outside of the European Economic Area with a focus on the Middle East including North Africa (Algeria, Iran, Israel, Lebanon, UAE) Asia Pacific (China, Hong Kong, Myanmar, South Korea, Phillippines, Taiwan, Thailand), Eastern Europe (Russia; Ukraine) and South America (Brasil, Columbia, Peru).
Development and Implementation of Registration Strategy for Ukraine and Eurasian Economic Union.

Market Access, Qualitätsmanagement (allg.), Regulatory Affairs

4/2014 – 9/2015

Auditierung Projekt

Auditor, Qualitätsmanagement (allg.)