Freelancer profile translated to English.

Description

Regulatory requirements under MDR, IVDR, and GMP are becoming increasingly complex – at the same time, many companies lack the resources to efficiently implement documentation, quality processes, and regulatory strategies.

This is exactly where I provide support.

I assist pharmaceutical, medtech, and IVD companies with the implementation of regulatory requirements, the structuring of technical documentation, and the optimization of quality and compliance processes.

Myfocus areasareRegulatory Affairs, Quality Management, and Clinical/Performance Evaluation.This includes in particular the creation and revision of technical documentation(CER, PER),the implementation and further development of quality management systems according toISO 13485 and GMP,as well as the handling of complex deviations, root cause analyses, and CAPA processes.

Furthermore, I support companies with Post-Market Surveillance(PMS), PMCF,and vigilance processes, as well as with the analysis and evaluation of clinical and performance data in the regulatory context.

Through my combination of regulatory expertise, practical experience in the laboratory environment, and many years of work in GMP-regulated quality management, I can support projects both strategically and operationally – from gap analysis through implementation to sustainable process optimization.

I support companieson a project basis or on an interim basis,particularly with MDR/IVDR implementations, technical documentation, CAPA and deviation management, and regulatory strategy issues.

A special focus is onIVDR transition projects(IVDD → IVDR) and on supporting medical diagnostic laboratories with the implementation of IVDR requirements for Laboratory Developed Tests(LDTs)according toIVDR (Article 5(5)).

Industry field of expertise

Languages

German
Native or bilingual
English
Conversational

Workplace preferences

Can work on-site

Lüneburg (up to 50km)

Enyara GmbH
Founder & Managing Director
MEDICAL
August 2021 - Today (4 years and 10 months)
Lüneburg, Germany
Consulting for pharmaceutical, medtech, and IVD companies in the areas of Regulatory Affairs, Quality Management, and Clinical Affairs with a focus on MDR, IVDR, and GMP regulated environments.
Advising companies on deviation, non-conformance, and CAPA management, as well as on optimizing quality processes.
Support in the creation and structuring of technical documentation for medical devices and IVDs according to MDR and IVDR (including CER and PER).
Development of regulatory and market access strategies for international markets (EU, FDA, UKCA, Swissmedic).
Implementation and optimization of quality management systems according to ISO 13485 and GxP.
Support for Post-Market Surveillance (PMS), PMCF, and vigilance systems according to MDR/IVDR.
Creation and optimization of SOPs and processes for clinical trials, as well as safety and AE management.
Medical-scientific evaluation and analysis of clinical data, including AE/SAE assessment and MedDRA coding.
Quality Management Systems Deviation & CAPA Management Quality control & laboratory analysis Medical Writing MDR 2017/745
Biotest
Regulatory & Quality Management Consultant
PHARMACEUTICALS INDUSTRY
July 2022 - December 2025 (3 years and 5 months)
Frankfurt am Main, Germany
Project-based support of quality management in a GMP-regulated biopharmaceutical production environment with a focus on deviation management, root cause analyses, and CAPA systems.

Leadership and coordination of deviation investigations in the production environment.
Execution of structured root cause analyses (e.g., 5M, Ishikawa, process analyses).
Evaluation of process deviations and manufacturing parameters in biopharmaceutical production.
Derivation, evaluation, and tracking of Corrective and Preventive Actions (CAPA).
Creation and review of GMP-compliant deviation reports, as well as trend and risk analyses.
Close collaboration with production, engineering, QA, and technical departments for root cause clarification and process improvement.
Ensuring GMP compliance and regulatory traceability within the quality management system.
Deviation & CAPA Management Root Cause Analysis GMP
Andreas Hettich GmbH
Regulatory Affairs Manager
November 2021 - February 2024 (2 years and 3 months)
Tuttlingen, Germany
Technical Documentation Lead – MDR / IVDR
Interdisciplinary coordination between Regulatory Affairs, Clinical Affairs, and Quality Management to prepare regulatory submissions.
Leadership and coordination of Technical Documentation according to MDR and IVDR.
Creation and maintenance of regulatory documentation, including Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER).
Ensuring conformity with European regulatory requirements.
Coordination with R&D, Quality Management, and Regulatory Affairs for the preparation of technical evidence.
MDR (EU 2017/745) IVDR 2017/746 Technical Documentation