Lars Koste

Quality Management & Regulatory Affairs

Löningen, Germany

Experience

Aug 2023 - Nov 2024
1 year 4 months
Tuttlingen, 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 2021 - Dec 2022
1 year
Münster, 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 months
Hamburg, 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 months
Munich, Germany

Quality management project

TOMTEC (Philips Konzern)

  • Audit preparation and follow-up (MDSAP)
  • Supplier management
  • CAPA management and project coordination
Nov 2018 - Dec 2020
1 year 2 months
Cologne, 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 month
Stuttgart, 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 months
Germany

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 months
Bergisch 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 months
Mainz, 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
Native
English
Advanced

Education

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