Holger Landau
Regulatory Affairs Manger, Quality Manager and Technical Writer
Experience
Apr 2025 - Present
4 monthsRegulatory Affairs Manager
Andreas Hettich GmbH
- Managing regulatory affairs for medical devices
- Ensuring compliance with relevant regulations and standards
Jul 2024 - Apr 2025
10 monthsCEO
media-tipps GmbH
- Leading the company’s strategic direction and operations
- Overseeing business development and client relations
Feb 2024 - Jun 2024
5 monthsAudit Manager / Deviation Management / CAPA
Maquet / Getinge
- Conducting audits and deviation management
- Implementing and managing corrective and preventive actions (CAPA)
Sep 2022 - Jan 2024
1 year 5 monthsRA Manager
VDW GmbH
- Managing approvals in different countries
- Leading Medical Device Regulation (MDR) compliance efforts
Apr 2022 - Sep 2022
6 monthsComplaint Manager and CAPA Manager
Weidmann Medical Technology AG
- Handling customer complaints and managing CAPA processes
- Ensuring quality and regulatory compliance
Oct 2021 - Apr 2022
7 monthsRA Manager
Johnson & Johnson
- Managing Swiss exit, contracts, labelling, MDR and registrations
Feb 2021 - Sep 2021
8 monthsRA Manager
Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (BEGO)
- Securing regulatory approvals for Canada, Russia, China, etc.
Sep 2020 - Jan 2021
5 monthsQM Consultant
medi GmbH
- Consulting on MDR and MDSAP
- Preparing technical files
Nov 2019 - Jun 2020
8 monthsTechnical Writer, QA
Ulrich Medical GmbH
- Updating technical file to MDR standards
- Managing biocompatibility evaluations and labelling
May 2019 - Nov 2019
7 monthsRegulatory Affairs Manager
Paul Hartmann AG
- Developing regulatory strategies for MDR and various products
- Preparing responsible documentation
Jun 2018 - Apr 2019
11 monthsRegulatory Affairs Manager
Dentsply Sirona
- Managing international registrations of dental implants and instruments (USA 510k, China, Russia, India, Brazil)
- Updating technical file to MDR, including ISO 10993-1 biocompatibility and labelling
Aug 2017 - Nov 2019
2 years 4 monthsQM Manager (Lead)
KAIA Health
- Acting as external quality management representative (QMB)
- Managing QM system, SOPs, internal and external audits
- Supporting supplier QA, product conformity certification, root cause analysis, and NPI support
May 2017 - Apr 2018
1 yearQA/RA Manager
Trumpf Medical
- Handling regulatory affairs and international product registrations (USA, Brazil, China, FDA 510k)
- Conducting MDR and ISO 13485:2016 gap analysis, UDI and GSPR compliance
- Creating technical file summary reports, essential requirement checklists, and applied standards lists
Sep 2016 - Apr 2017
8 monthsQA Manager
Leica Microsystems
- Establishing CAPA management per FDA requirements and processing FDA deviations
- Supporting FDA audits and post market surveillance
- Managing CAPA, validations, customer complaints, risk management, document control, management reviews, MDSAP, training, and audits
- Preparing QM performance reports and metrics
Aug 2015 - Dec 2015
5 monthsQA Manager
Roche Diabetes Care
- Performing risk management (IEC 60601 series), gap analysis, evaluation, FMEA for FDA requirements of an IVDR device
- Supporting FDA audits and complaint handling
- Executing safety board notifications and liaising with local authorities
- Establishing and maintaining QMS, implementing RDC standards, and conducting internal and external audits
Mar 2015 - Aug 2016
1 year 6 monthsQA Manager (Lead)
Dewimed
- Acting as external QMB and managing audits by notified bodies, regional council, and FDA
- Developing a new QM system, processing deviations, action plans, and process improvements
- Editing and creating clinical evaluations, CAPA, SOPs, user manuals, procedures, biocompatibility (ISO 10993-1), and labels
- Introducing post market surveillance, risk management, change management, and a new Q-system
- Securing product approvals in Europe, Asia, and USA (510k) with STED documentation
Oct 2014 - Jan 2015
4 monthsQA Manager
Johnson & Johnson
- Technical editing for implants sector: quality and CSV documents, sterilisation, validation, and cleaning documentation
Oct 2013 - Jun 2014
9 monthsQA Manager
Roche Diagnostics
- Freelance technical writer and quality manager for pharmaceutical and medical devices
- Transferring blood analysing devices from Austria to Switzerland
- Preparing product and manufacturing documentation per FDA requirements, including validation and process documents, GMP-compliant QM documentation, and compliance with ISO 13485 and ISO 14791
Jul 2010 - Sep 2013
3 years 3 monthsTechnical Editor
TOX
- Preparing operating instructions, service manuals, and other required documents
- Supporting website content and creating brochures and promotional materials
- SAP user
Dec 2009 - Jun 2010
7 monthsCommunication Manager
Commerzbank AG
- Creating internal and external newsletters
- Managing communication flow and planning
- Delivering presentations and leadership in communication projects
Jun 2006 - Nov 2009
3 years 6 monthsTechnical Writer and Q-Manager
MTS
- Preparing user manuals, service manuals, marked component documentation, work and test instructions, and software documents in English and German
- Authorising Class IIb and III medical devices for USA, Asia, and Europe, including risk analysis, verification and validation documents, instructions for use, specifications, work instructions, and labelling
- Preparing CE approval documents for Class IIb and Class III (cardio) devices
- Participating in FDA audits, CE certifications, and multiple 510k submissions (lithotripters and shock wave devices)
Jan 2001 - Jun 2006
5 years 6 monthsJournalist
Freelance
- Writing for Stuttgarter Zeitung, Süddeutsche Zeitung, CHIP, PC Professional, Soundcheck, Spectrum of Science, and other magazines
- Covering HiFi, music, computer peripherals, music electronics, instruments, software, scientific topics, electronics, economics, and courses
Jan 1999 - Dec 2002
2 yearsEditor
Lehrinstitut Onken
- Creating textbooks for correspondence courses in PC applications
Jan 1998 - Dec 2000
3 yearsEditor
Vogel Verlag
- Editing and writing articles for CHIP magazine, including product overviews and presentations
Jan 1997 - Dec 1998
2 yearsEditor
Bruchmann Verlag
- Editing and writing articles for ELRAD magazine, including product overviews and presentations
Jan 1996 - Dec 1998
2 yearsTechnical Editor
B.L.E.
- Creating manuals in mechanical engineering sector
Jan 1992 - Dec 1997
5 yearsTechnical Writer
Perkin-Elmer
- Creating technical manuals, operating instructions, software descriptions, short instructions
- Designing, managing, and archiving documents
- Creating change messages, PR materials, and advertising content
Jan 1991 - Dec 1992
2 yearsElectronic Technician
Perkin-Elmer
- Building and testing experimental circuits and devices
- Conducting material investigations and circuit modifications
- Creating change messages, test instructions, and development logs
Jan 1990 - Dec 1992
2 yearsService Technician
Perkin-Elmer
- Providing worldwide service for environmental and process analyzers
- Conducting customer seminars and telephone support
- Creating service messages
Jan 1986 - Dec 1991
5 yearsInformation Electronics Specialist
Bodenseewerk Perkin-Elmer
- Working in electronics production with various responsibilities
Languages
German
Native
English
Advanced
Education
Oct 1984 - Sep 1986
Bfw
Apprenticeship · Information Electronics · Schömberg, Germany
Certifications & licenses
Managementsysteme für Hersteller von Medizinprodukten
TÜV SÜD Akademie GmbH
Specialist Managementsystems - TÜV
TÜV SÜD Akademie GmbH
Canadian Medical Devices Conformity Assessment System (CMDCAS)
Regular Services GbR
DUDEN training! zur neuen deutschen Rechtschreibung
Vogel Verlag
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