Lars Koste - Temporary Head of Quality Management & Regulatory Affairs

Q: Where is Lars based?

Lars is based in Löningen, Germany .

Q: What languages does Lars speak?

Lars speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Lars have?

Lars has at least 15 years of experience. During this time, Lars has worked in at least 9 different roles and for 8 different companies . The average length of individual experience is 2 years and 8 months . Note that Lars may not have shared all experience and actually has more experience.

Q: What is Lars's latest experience?

Lars's most recent position is Temporary Head of Quality Management & Regulatory Affairs at Medical device manufacturer .

Q: What companies has Lars worked for in recent years?

In recent years, Lars has worked for Medical device manufacturer , Manufacturer , Bundeswehr Krankenhaus Hamburg , and Freelancer / Consultant .

Q: Which industries is Lars most experienced in?

Lars is most experienced in industries like Biotechnology , Healthcare , and Pharmaceutical .

Q: Which business areas is Lars most experienced in?

Lars is most experienced in business areas like Product Development , Project Management , and Quality Assurance . Lars also has some experience in Research and Development , Legal , and Supply Chain Management .

Q: Which industries has Lars worked in recently?

Lars has recently worked in industries like Healthcare , Biotechnology , and Pharmaceutical .

Q: Which business areas has Lars worked in recently?

Lars has recently worked in business areas like Quality Assurance , Product Development , and Project Management .

Recommended expert

Löningen, Germany

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Experience

Aug 2023 - Nov 2024

1 year 4 months

Tuttlingen, Germany

Temporary Head of Quality Management & Regulatory Affairs

Medical device manufacturer

Temporary leadership of the Quality Management & Regulatory Affairs department
Restructuring from 5 to 10+ internal and external staff
Technical documentation
Risk management (ISO 14971, FMEAs)
Digitization projects
Regulatory affairs
Quality management
Change management
Clinical affairs (clinical and performance evaluations)

Jan 2022 - Dec 2022

1 year

Münster, Germany

Project Coordinator

Manufacturer

Regulatory affairs
R&D
Biocompatibility studies
In vivo animal studies (preclinical)
Study design and evaluation
Prototyping & scale-up

Mar 2020 - Jun 2021

1 year 4 months

Hamburg, Germany

Lab Head

Bundeswehr Krankenhaus Hamburg

Laboratory management
Establishment of assay & test systems (multi-PCR)
Scientific medical advisor
Vaccine consulting and education

Jan 2019 - Apr 2019

4 months

Munich, Germany

Quality Management Project

TOMTEC (Philips Group)

Audit preparation and follow-up (MDSAP)
Supplier management
CAPA management
Project coordination

Nov 2018 - Dec 2019

1 year 2 months

Cologne, Germany

Deputy Project Manager

FARCO Pharma

Deputy project management and coordination of QM, RA, clinical, PMS/PV & marketing with TÜV Süd
Update to MDR and ISO 13485:2016

Sep 2017 - Sep 2018

1 year 1 month

Stuttgart, Germany

PMCF Study Manager

Medical device manufacturer

Clinical studies according to the Medical Devices Act (MPG)
Contract negotiation and coordination with CROs
Preparation of study documents
Project coordination for EU MDR transition

Feb 2016 - Present

10 years 4 months

Freelancer / Consultant

Coordination of clinical evaluations/performance evaluations and usability studies (human factors)
Design and conduct of clinical studies (ISO 14155)
Risk management (ISO 14971)
Clinical studies (Phase I-IV, PMCF, EU MDR)
Study documentation (eCRF)
Post-market surveillance studies (PMS)
Vaccine development in oncology and virology (GMP)
Regulatory frameworks
Planning of animal studies (preclinical, FELASA, GV-SOLAS)
Coordination with authorities (BfArM, PEI and FDA) and notified bodies (TÜV Süd)
Preparation of patents according to European (EPA) and US standards (USPTO)
Technology transfer & scale-up
QM systems (ISO 9001/13485, GMP, FDA)
Audit preparation and follow-up (MDSAP, FDA, MDR, AMG, GxP)
Technical documentation (product dossiers)
Risk management (ISO 14971, FMEAs)
CAPA management
Preparation of standard procedures (SOPs, Quality Manual, hygiene manual)
Coordination with drug authorities (BfArM, PEI, EMA, FDA) and compliance with international standards (GxP, EU MDR, FDA 21 CFR 820, ISO 9001/13485/14971)
Organization of project environments and adherence to project plans
Efficient leadership of team consultations
Alignment of project objectives and stakeholder interests (KOL management)
Leadership of project teams and business processes
Business administration in project management
Legal aspects, project and product marketing, project controlling
Change management, rational project planning and control
Implementation of goals and milestones, execution of multiple projects
Technology transfer (from preclinical to GMP)
Certified project management professional (GPM and IPMA, Level D)

Sep 2015 - Dec 2015

4 months

Bergisch Gladbach, Germany

Trainee, Clinical Development

Miltenyi Biotec GmbH

Management & planning of clinical studies (GCP, ICH E6, AMG & MPG)

May 2010 - Sep 2014

4 years 5 months

Mainz, Germany

Research Associate

Institut für Translationale Onkologie (TRON gGmbH)

Gene and immunotherapies (GMP)
Technology transfer
Joint venture with EUFETS GmbH & BioNTech AG

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Biotechnology, Healthcare, and Pharmaceutical.

Biotechnology

Healthcare

Pharmaceutical

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Product Development, Quality Assurance, Project Management, Research and Development, Legal, and Supply Chain Management.

Product Development

Quality Assurance

Project Management

Research and Development

Legal

Supply Chain Management

Skills

Clinical Studies And Regulatory Affairs

Coordination Of Clinical Evaluations / Performance Evaluations And Usability Studies (Human Factors)
Design And Conduct Of Clinical Studies (Iso 14155)
Risk Management (Iso 14971)
Clinical Studies (Phase I-Iv, Pmcf, Eu Mdr)
Study Documentation (Ecrf)
Post-Market Surveillance (Pms) Studies
Vaccine Development In Oncology And Virology (Gmp)
Legal Frameworks
Planning Of Animal Studies (Preclinical, Felasa, Gv-Solas)
Coordination With Authorities (Bfarm, Pei And Fda) And Notified Bodies (TÜV SüD)
Patent Drafting According To European (Epo) And Us (Uspto) Standards
Technology Transfer & Scale-Up

Quality Management

Qms (Iso 9001/13485, Gmp, Fda)
Audit Preparation And Follow-Up (Mdsap, Fda, Mdr, Amg, Gxp)
Technical Documentation (Product Files)
Risk Management (Iso 14971, Fmeas)
Capa Management
Creation Of Standard Procedures (Sops, Qmh, Hygiene Manual)
Coordination With Drug Authorities (Bfarm, Pei, Ema, Fda)
Compliance With International Standards (Gxp, Eu Mdr, Fda 21 Cfr 820 And Iso 9001/13485/14971)

Project Management

Organization Of Project Environments
Steering And Adherence To Project Plans
Efficient Leadership Of Team Meetings
Linking Project Goals And Stakeholder Interests (Kol Management)
Leading Project Teams And Business Processes
Business Administration In Project Management
Legal Aspects
Project And Product Marketing
Project Controlling
Change Management
Rational Project Planning And Control
Implementation Of Goals And Milestones
Running Multiple Projects
Technology Transfer (From Preclinical To Gmp)
Certified Project Manager (Gpm And Ipma, Level D)

Languages

German

Native

English

Advanced

Education

Jun 2009 - Aug 2014

University Medical Center Mainz, Hematology III, Medical Department

PhD in Applied Oncology · Applied Oncology · Mainz, Germany

Certifications & licenses

Internal Auditor for ISO 13485

TÜV Süd

Project Manager Certification in Clinical Research and Biosciences

mibeg-Institut Medizin

Certified Project Manager GPM/IPMA

Statistics

Experience

Total positions 9

Experience in Biotechnology 15 y

Avg length 2 y 3 m

Longest experience 10 y 3 m

Global Experience

Countries worked in 1 (Germany)

Primary country Germany

Expertise

Recent roles Temporary Head of Quality Management & Regulatory Affairs, Project Coordinator, Lab Head

Main industries Biotechnology, Healthcare, Pharmaceutical

Main business areas Product Development, Quality Assurance, Project Management

Qualifications

Highest degree Doctorate

Certifications earned 3

Profile

Created

June 2025

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Frequently asked questions

Have questions? Find more information here.

Where is Lars based?

Lars is based in Löningen, Germany.

What languages does Lars speak?

Lars speaks the following languages: German (Native), English (Advanced).

How many years of experience does Lars have?

Lars has at least 15 years of experience. During this time, Lars has worked in at least 9 different roles and for 8 different companies. The average length of individual experience is 2 years and 8 months. Note that Lars may not have shared all experience and actually has more experience.

What roles would Lars be best suited for?

Based on recent experience, Lars would be well-suited for roles such as: Temporary Head of Quality Management & Regulatory Affairs, Project Coordinator, Lab Head.

What is Lars's latest experience?

Lars's most recent position is Temporary Head of Quality Management & Regulatory Affairs at Medical device manufacturer.

What companies has Lars worked for in recent years?

In recent years, Lars has worked for Medical device manufacturer, Manufacturer, Bundeswehr Krankenhaus Hamburg, and Freelancer / Consultant.

Which industries is Lars most experienced in?

Lars is most experienced in industries like Biotechnology, Healthcare, and Pharmaceutical.

Which business areas is Lars most experienced in?

Lars is most experienced in business areas like Product Development, Project Management, and Quality Assurance. Lars also has some experience in Research and Development, Legal, and Supply Chain Management.

Which industries has Lars worked in recently?

Lars has recently worked in industries like Healthcare, Biotechnology, and Pharmaceutical.

Which business areas has Lars worked in recently?

Lars has recently worked in business areas like Quality Assurance, Product Development, and Project Management.

What is Lars's education?

Lars holds a Doctorate in Applied Oncology from University Medical Center Mainz, Hematology III, Medical Department.

Does Lars have any certificates?

Lars has 3 certificates. These include: Internal Auditor for ISO 13485, Project Manager Certification in Clinical Research and Biosciences, and Certified Project Manager GPM/IPMA.

What is the availability of Lars?

Lars is immediately available for suitable projects.

What is the rate of Lars?

Lars's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.