Holger Landau - Regulatory Affairs Manager

Q: Where is Holger based?

Holger is based in Mols, Switzerland and can operate in on-site , hybrid , and remote work models.

Q: What languages does Holger speak?

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

Q: How many years of experience does Holger have?

Holger has at least 39 years of experience. During this time, Holger has worked in at least 23 different roles and for 27 different companies . The average length of individual experience is 1 year and 4 months . Note that Holger may not have shared all experience and actually has more experience.

Q: What is Holger's latest experience?

Holger's most recent position is Regulatory Affairs Manager at Andreas Hettich GmbH .

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

In recent years, Holger has worked for Andreas Hettich GmbH , media-tipps GmbH , Maquet / Getinge , VDW GmbH , and Weidmann Medical Technology AG .

Q: Which industries is Holger most experienced in?

Holger is most experienced in industries like Manufacturing , Healthcare , and Media and Entertainment . Holger also has some experience in Biotechnology , Education , and Information Technology .

Q: Which business areas is Holger most experienced in?

Holger is most experienced in business areas like Product Development , Marketing , and Quality Assurance . Holger also has some experience in Research and Development , Production , and Legal .

Q: Which industries has Holger worked in recently?

Holger has recently worked in industries like Healthcare , Manufacturing , and Media and Entertainment .

Q: Which business areas has Holger worked in recently?

Holger has recently worked in business areas like Legal , Quality Assurance , and Strategy .

Recommended expert

Mols, Switzerland

Experience

Apr 2025 - Present

1 year

Tuttlingen, Germany

Regulatory Affairs Manager

Andreas Hettich GmbH

Jul 2024 - Apr 2025

10 months

Quarten, Switzerland

CEO

media-tipps GmbH

Feb 2024 - Jun 2024

5 months

Rastatt, Germany

Audit Manager / Deviation Management / CAPA

Maquet / Getinge

Sep 2022 - Jan 2024

1 year 5 months

Munich, Germany

Regulatory Affairs Manager / Approvals in different countries / MDR

VDW GmbH

Apr 2022 - Sep 2022

6 months

Switzerland

Complaint Manager and CAPA Manager

Weidmann Medical Technology AG

Oct 2021 - Apr 2022

7 months

Germany

RA Manager

Johnson & Johnson

Swixit, contracts, labelling, MDR and registrations

Feb 2021 - Sep 2021

8 months

Bremen, Germany

RA Manager / Approval for Canada, Russia, China etc.

Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (BEGO)

Sep 2020 - Jan 2021

5 months

Bayreuth, Germany

QM-Consult

medi GmbH

MDR and MDSAP consulting
Technical file

Nov 2019 - Jun 2020

8 months

Ulm, Germany

Technical Writer, QA

Ulrich Medical GmbH

Updating technical file to MDR including biocompatibility and labels

May 2019 - Nov 2019

7 months

Heidenheim, Germany

Regulatory Affairs Manager

Paul Hartmann AG

Development of regulatory strategies for MDR and different products including responsible documents

Jun 2018 - Apr 2019

11 months

Mannheim, Germany

Regulatory Affairs Manager

Dentsply Sirona

International registrations of dental implants and instruments (USA 510k, China, Russia, India, Brazil)
Updating technical file to MDR including biocompatibility (ISO 10993-1) and labels

Aug 2017 - Nov 2019

2 years 4 months

Munich, Germany

QM Manager (Lead)

KAIA Health

External QMB
Managing the QM system, internal and external audits, SOPs, supporting supplier QA activities
Supporting projects in interpretation of quality plans, reviewing and approving products under certificate of conformity
Carrying out root cause investigations of non-conformances and supporting NPI

May 2017 - Apr 2018

1 year

Puchheim, Germany

QA/RA Manager

Trumpf Medical

Regulatory affairs and international registrations and approvals of medical products (USA, Brazil, China, FDA 510k)
Application of new MDR, ISO 13485:2016 and PMS
Performing a GAP analysis for MDR covering UDI and general safety and performance requirements
Creating technical file summary reports, essential requirement checklists and lists of applied standards

Sep 2016 - Apr 2017

8 months

Au, Switzerland

QA Manager

Leica Microsystems

Establishing CAPA management in accordance with FDA requirements, processing and editing FDA deviations, accompanying FDA audits
Applying new MDR and ISO 13485:2016 for post market surveillance
Owning elements of the quality system including CAPA, validations, customer complaints, risk management, document control, management reviews, MDSAP, training and internal and party audits
Preparing performance reports and metrics for QMS and assisting other departments in data management to support quality objectives

Aug 2015 - Dec 2015

5 months

Mannheim, Germany

QA Manager

Roche Diabetes Care

Risk management (60601-x-x), gap analysis, evaluation and FMEA for FDA requirements for an IVDR device
Accompanying FDA audits
Complaint handling and execution of safety board notifications as primary contact for local authorities
Management of regulatory submissions under LRSO responsibility
Establishing QMS and supervising documentation management
Implementing Roche Diabetes Care standards in local processes
Supporting internal and external audits including affiliate oversight and certification audits

Mar 2015 - Aug 2016

1 year 6 months

Germany

QA Manager (Lead)

Dewimed

Acting as external QMB
Auditing notified bodies, regional council and FDA
Developing a new QM system, processing deviations and conducting regional council audits
Editing and creating clinical evaluations, CAPA, SOPs, user manuals, procedures, biocompatibility (ISO 10993-1) and labels
Introducing post market surveillance, risk management and change management
Creating a new QMH and Q-system
Approving new products in Europe, Asia and USA (510k) and preparing technical documentation according to STED

Oct 2014 - Jan 2015

4 months

Switzerland

QA Manager

Johnson & Johnson

Technical editor in the implants sector for quality and CSV documents and other validation documents
Sterilisation, validation and cleaning

Oct 2013 - Jun 2014

9 months

Switzerland

QA Manager

Roche Diagnostics

Freelance technical writer and quality manager in pharmaceutical and medical device industry
Transferring blood analysing devices from Austria to Switzerland
Preparing product and manufacturing documentation according to FDA requirements including SAP use, validation and process documents, GMP-compliant QMS documentation and ISO 13485 and ISO 14791 standards

Jul 2010 - Sep 2013

3 years 3 months

Ravensburg, Germany

Technical Editor

TOX

Preparing operating instructions, service manuals and other required documents
Supporting internet pages
Creating brochures and promotional material
SAP user

Dec 2009 - Jun 2010

7 months

Frankfurt, Germany

Communication Manager

Commerzbank AG

Creating newsletters for employees and external presentations
Controlling communication flow
Leadership and presentations
Communication planning

Jun 2006 - Nov 2009

3 years 6 months

Konstanz, Germany

Technical Writer and Q-Manager

MTS

Preparing user manuals, service manuals and documents (marked components, work instructions, test instructions, software documents) in English and German
Authorising Class IIb and III devices in USA, Asia and Europe (risk analysis, verification/validation documents, instructions for use, specifications, work instructions, labelling)
Preparing documents for CE approval of Class IIb and Class III (cardio) devices
Participating in FDA audits and CE certifications
Preparing 510k submissions for lithotripters and shock wave devices

Jan 2001 - Jun 2006

5 years 6 months

Germany

Freelance Journalist

Working for Stuttgarter Zeitung, Süddeutsche Zeitung, CHIP, PC Professional, Soundcheck, Spectrum of Science and other magazines
Covering topics such as HiFi, music, computers and peripherals, music electronics, musical instruments, software, scientific and economic topics

Jan 2000 - Dec 2001

2 years

Switzerland

Editor in teaching aids sector

Lehrinstitut Onken

Creating textbooks for correspondence courses in PC applications

Jan 1998 - Dec 2000

3 years

Munich, Germany

Editor

Vogel Verlag

Editing articles and writing own articles including title topics
Creating product overviews and presentations

Jan 1997 - Dec 1998

2 years

Munich, Germany

Editor

Bruchmann Verlag

Editing and writing articles
Creating product overviews and presentations

Jan 1996 - Dec 1997

2 years

Radolfzell, Germany

Technical Editor

B.L.E.

Creating manuals

Jan 1992 - Dec 1996

5 years

Überlingen, Germany

Technical Writer

Perkin-Elmer

Creating technical manuals, operating instructions, software descriptions and short instructions
Designing documents, managing and archiving documentation
Creating change messages, public relations and advertising material

Jan 1991 - Dec 1992

2 years

Überlingen, Germany

Electronic Technician

Perkin-Elmer

Constructing experimental circuits and testing devices
Conducting material investigations and circuit modifications
Creating change messages, test instructions and development logs

Jan 1990 - Dec 1991

2 years

Überlingen, Germany

Service Technician

Perkin-Elmer

Providing worldwide service for environmental and process analyzers
Conducting customer seminars and offering telephone support and advice
Creating service messages

Jan 1986 - Dec 1990

5 years

Überlingen, Germany

Information Electronics

Bodenseewerk Perkin-Elmer

Working in information electronics in production with various tasks

Industry Experience

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

Experienced in Manufacturing, Healthcare, Media and Entertainment, Biotechnology, Education, and Information Technology.

Manufacturing

Healthcare

Media and Entertainment

Biotechnology

Education

Information Technology

Business Area Experience

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

Experienced in Product Development, Marketing, Quality Assurance, Research and Development, Production, and Legal.

Product Development

Marketing

Quality Assurance

Research and Development

Production

Legal

Skills

Extensive Experience In Medical Directives And Formalities, E.g., Din Iso 13485 Medical Device Directive (Mdd), Mdr, Iso 13485, En 60601-x-x, And Fda (21 Cfr Part 820) Regulations. Familiar With Robert Koch Institute Guidelines, Iso 15883, Iso 17665, Iso 17664, Risk Management, Capa, Supply Management, Change Management, Iso 14971, Iso 10993-.
In-depth Knowledge Of Quality Systems And Regulations In Europe, The Usa, Japan, China, South America (Brazil, Etc.), And More.
Extensive Experience With Pharmaceutical Regulations, E.g., Gmp.
Strong Communication Skills.
Excellent Writing In German And English.
Quick Thinking.
Analytical Mindset.
Flexible

Languages

German

Native

English

Advanced

Education

Oct 1984 - Jun 1986

Bfw

Apprenticeship for Information Electronics · Information Electronics · Schömberg, Germany

Certifications & licenses

Specialist Management Systems (TÜV Certificate)

Canadian Medical Devices Conformity Assessment System (Certificate)

Dudentraing (Certificate)

Statistics

Experience

Total positions 30

Experience in Manufacturing 13 y

Avg length 1 y 7 m

Longest experience 5 y 5 m

Global Experience

Countries worked in 2 (Germany, Switzerland)

Primary country Germany

Expertise

Recent roles Regulatory Affairs Manager, CEO, Audit Manager / Deviation Management / CAPA

Main industries Manufacturing, Healthcare, Media and Entertainment

Main business areas Product Development, Marketing, Quality Assurance

Qualifications

Certifications earned 3

Profile

Created

July 2025

Last Update

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Holger based?

Holger is based in Mols, Switzerland and can operate in on-site, hybrid, and remote work models.

What languages does Holger speak?

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

How many years of experience does Holger have?

Holger has at least 39 years of experience. During this time, Holger has worked in at least 23 different roles and for 27 different companies. The average length of individual experience is 1 year and 4 months. Note that Holger may not have shared all experience and actually has more experience.

What roles would Holger be best suited for?

Based on recent experience, Holger would be well-suited for roles such as: Regulatory Affairs Manager, CEO, Audit Manager / Deviation Management / CAPA.

What is Holger's latest experience?

Holger's most recent position is Regulatory Affairs Manager at Andreas Hettich GmbH.

What companies has Holger worked for in recent years?

In recent years, Holger has worked for Andreas Hettich GmbH, media-tipps GmbH, Maquet / Getinge, VDW GmbH, and Weidmann Medical Technology AG.

Which industries is Holger most experienced in?

Holger is most experienced in industries like Manufacturing, Healthcare, and Media and Entertainment. Holger also has some experience in Biotechnology, Education, and Information Technology.

Which business areas is Holger most experienced in?

Holger is most experienced in business areas like Product Development, Marketing, and Quality Assurance. Holger also has some experience in Research and Development, Production, and Legal.

Which industries has Holger worked in recently?

Holger has recently worked in industries like Healthcare, Manufacturing, and Media and Entertainment.

Which business areas has Holger worked in recently?

Holger has recently worked in business areas like Legal, Quality Assurance, and Strategy.

What is Holger's education?

Holger attended Bfw for Information Electronics.

Does Holger have any certificates?

Holger has 3 certificates. These include: Specialist Management Systems (TÜV Certificate), Canadian Medical Devices Conformity Assessment System (Certificate), and Dudentraing (Certificate).

What is the availability of Holger?

Holger is immediately available full-time for suitable projects.

What is the rate of Holger?

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