Clinical Affairs / Quality Management / Vigilance / PRRC

7/2023 – 7/2025

Regulatory strategies
Devices registration in Europe / Asia / Saudi Arabia / USA
Quality Management according to ISO 13485
Person Responsible for Regulatory Compliance

Qualitätsmanagement / QS / QA (IT), Regulatory Affairs

1/2018 – 10/2022

Clinical strategies for medical devices for ventilation therapy and anesthesia
Clinical Evaluations and Post Market Clinical Follow-Ups according to MDR Literature Search according to Evidence-Based Medicine
Process Owner for global SOPs for Clinical Evaluation Report / PMCF Implementation of regulatory requirements according to MDR and MDCG guidelines Audits according to ISO13485, ISO14155 and MDR (Clinical Audit)

Anästhesie

8/2011 – 12/2017

Sicherheitsbeauftragte für Medizinprodukte (MPG)
QPPV
Stufenplanbeauftragte according to AMG §63a for wound and hands disinfectants
Cosmetovigilance

Pharma
Setup of the pharmacovigilance system, PSMV
Signal management (GVP Module IX)
PSURs (EU-Directive 2001/83/EC and GVP Module VII) Risk Management Plans (GVP Module V)
Adverse reactions reporting (GVP Module VI) Literature monitoring
Inspections (incl. FDA) and Audits

Medical Devices
Risk management for Medical Devices (ISO14971)
Clinical Evaluation Reports
Periodic Safety Update reports

Cosmetics
Cosmetovigilance

Drug Discovery, Gute Klinische Praxis

9/2007 – 7/2011

PSURs, DSURs, Adverse reactions reporting, Clinical Expert Statements, Literature Search; for different drugs incl. analgesics and oncological therapeutics

Dienstleistung (allg.), F&E Management