Clinical Affairs / Quality Management / Vigilance / PRRC

7/2023 – offen

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

Scientific and Clinical Affairs
QPPV, Stufenplanbeauftragte according to AMG §63a for wound and hands disinfectants
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

Gute Klinische Praxis, Drug Discovery