Lars K.
Quality Management & Regulatory Affairs
Experience
Aug 2023 - Nov 2024
1 year 4 monthsTuttlingen, Germany
Temporary head of Quality Management & Regulatory Affairs
Medical device manufacturer
- Restructuring from 5 to 10+ internal and external staff
- Technical documentation and risk management (ISO 14971, FMEAs)
- Projects in digitalization, regulatory affairs, quality management, and change management
- Clinical affairs (clinical evaluations & performance evaluations)
Jan 2022 - Dec 2022
1 yearMünster, Germany
Project Coordinator for wound dressing approval
Medical device manufacturer
- Approval of a wound dressing under FDA & MDR (EU implant class III, FDA wound dressing)
- Regulatory affairs, R&D
- Biocompatibility tests and in vivo animal studies (pre-clinical)
- Study design and assessment
- Prototyping & scale-up
Mar 2020 - Jun 2021
1 year 4 monthsHamburg, Germany
Corona helper – Lab leader
Bundeswehr Krankenhaus Hamburg
- Lab management and setting up assay and test systems (multi-PCR)
- Scientific medical advisor: vaccine consulting and education
Jan 2019 - Apr 2019
4 monthsMunich, Germany
Quality management project
TOMTEC (Philips Konzern)
- Audit preparation and follow-up (MDSAP)
- Supplier management
- CAPA management and project coordination
Nov 2018 - Dec 2019
1 year 2 monthsCologne, Germany
Deputy project manager
FARCO Pharma (Klosterfrau Konzern)
- Coordination of QM, RA, clinical, PMS/PV & marketing with TÜV Süd
- Update to EU MDR and ISO 13485:2016
Sep 2017 - Sep 2018
1 year 1 monthStuttgart, Germany
PMCF study manager
Medical device manufacturer
- Conducting PMCF studies for class III medical devices under MPG
- Contract negotiations and coordination with CRO
- Preparation of study documents
- Project coordination for transition to EU MDR
Feb 2016 - Present
9 years 6 monthsGermany
Freelancer / Consultant
Freelancer / Consultant
- Project and quality management
- Clinical trials (GCP)
- QM systems ISO 9001, ISO 13485, ISO 14155, ISO 14971
- Audit preparation and follow-up (FDA, EU MDR / MDD, MDSAP, GxP)
Sep 2015 - Dec 2015
4 monthsBergisch Gladbach, Germany
Trainee Clinical Development
Miltenyi Biotec GmbH
- Management and planning of clinical trials (GCP, ICH E6, AMG & MPG)
May 2010 - Sep 2014
4 years 5 monthsMainz, Germany
Wissenschaftlicher Mitarbeiter
Institut für Translationale Onkologie (TRON gGmbH), Universitätsmedizin Mainz
- Research on gene and immunotherapies (GMP)
- Technology transfer in joint venture with EUFETS GmbH & BioNTech AG
Summary
Certified Project Manager GPM / IPMA, GCP audit preparation and follow-up EU MDR, FDA, MDSAP Quality management systems ISO 9001, ISO 13485
Languages
German
NativeEnglish
AdvancedEducation
Jun 2009 - Aug 2014
Universitätsmedizin Mainz
PhD in Applied Oncology, Hematology, 3rd Medical Department, Retroviral Gene Therapy, Immunotherapy & Oncology · Mainz, Germany
Certifications & licenses
Internal Auditor for ISO 13485
TÜV Süd
Certification as Project Manager for Clinical Research and Biosciences
mibeg-Institut Medizin
Certified Project Management Professional (GPM and IPMA, Level D)
GPM, IPMA
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