Holger Landau
Regulatory Affairs Manager
Experience
Apr 2025 - Present
10 monthsTuttlingen, Germany
Regulatory Affairs Manager
Andreas Hettich GmbH
Jul 2024 - Apr 2025
10 monthsQuarten, Switzerland
CEO
media-tipps GmbH
Feb 2024 - Jun 2024
5 monthsRastatt, Germany
Audit Manager / Deviation Management / CAPA
Maquet / Getinge
Sep 2022 - Jan 2024
1 year 5 monthsMunich, Germany
RA Manager / Approvals in different countries / MDR
VDW GmbH
Apr 2022 - Sep 2022
6 monthsSwitzerland
Complaint Manager and CAPA Manager
Weidmann Medical Technology AG
Oct 2021 - Apr 2022
7 monthsGermany
RA Manager
Johnson & Johnson
- Swixit, contracts, labelling, MDR and registrations
Feb 2021 - Sep 2021
8 monthsBremen, Germany
RA Manager / Approval for Canada, Russia, China etc.
Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (BEGO)
Sep 2020 - Jan 2021
5 monthsBayreuth, Germany
QM-Consult
medi GmbH
- MDR and MDSAP consulting
- Technical file
Nov 2019 - Jun 2020
8 monthsUlm, Germany
Technical Writer, QA
Ulrich Medical GmbH
- Updating technical file to MDR including biocompatibility and labels
May 2019 - Nov 2019
7 monthsHeidenheim, Germany
Regulatory Affairs Manager
Paul Hartmann AG
- Development of regulatory strategies for MDR and different products including responsible documents
Jun 2018 - Apr 2019
11 monthsMannheim, 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 monthsMunich, 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 yearPuchheim, 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 monthsAu, 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 monthsMannheim, 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 monthsGermany
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 monthsSwitzerland
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 monthsSwitzerland
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 monthsRavensburg, 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 monthsFrankfurt, 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 monthsKonstanz, 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 monthsGermany
Freelance Journalist
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 yearsSwitzerland
Editor in teaching aids sector
Lehrinstitut Onken
- Creating textbooks for correspondence courses in PC applications
Jan 1998 - Dec 2000
3 yearsMunich, Germany
Editor
Vogel Verlag
- Editing articles and writing own articles including title topics
- Creating product overviews and presentations
Jan 1997 - Dec 1998
2 yearsMunich, Germany
Editor
Bruchmann Verlag
- Editing and writing articles
- Creating product overviews and presentations
Jan 1996 - Dec 1997
2 yearsRadolfzell, Germany
Technical Editor
B.L.E.
- Creating manuals
Jan 1992 - Dec 1996
5 yearsÜberlingen, 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 yearsÜberlingen, 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 yearsÜberlingen, 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 yearsÜberlingen, Germany
Information Electronics
Bodenseewerk Perkin-Elmer
- Working in information electronics in production with various tasks
Skills
- Extensive Experience With Medical Directives And Formalities, For Example Din Iso 13485 (Medical Device Directive - Mdd), Mdr, Iso 13485, En 60601-x-x, And Fda 21 Cfr Part 820 Regulations. Knowledge Of Robert Koch Institute Guidelines, Iso 15883, Iso 17665, Iso 17664, Risk Management, Capa, Supply Management, Change Management, Iso 14971, And Iso 10993.
- Outstanding Knowledge Of Q-systems And Regulations In Europe, The Usa, Japan, China, South America (E.g., Brazil) And More
- Extensive Experience With Pharmaceutical Regulations, For Example Gmp
- Strong Communication Skills
- Excellent Written German And English
- Quick Thinking
- Analytical Thinking
- Flexible
Languages
German
NativeEnglish
AdvancedEducation
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)
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