Holger Landau
Regulatory Affairs Manger, Quality Manager and Technical Writer
Erfahrungen
Apr. 2025 - Bis heute
4 MonatenRegulatory Affairs Manager
Andreas Hettich GmbH
- Managing regulatory affairs for medical devices
- Ensuring compliance with relevant regulations and standards
Juli 2024 - Apr. 2025
10 MonatenCEO
media-tipps GmbH
- Leading the company’s strategic direction and operations
- Overseeing business development and client relations
Feb. 2024 - Juni 2024
5 MonatenAudit Manager / Deviation Management / CAPA
Maquet / Getinge
- Conducting audits and deviation management
- Implementing and managing corrective and preventive actions (CAPA)
Sept. 2022 - Jan. 2024
1 Jahr 5 MonatenRA Manager
VDW GmbH
- Managing approvals in different countries
- Leading Medical Device Regulation (MDR) compliance efforts
Apr. 2022 - Sept. 2022
6 MonatenComplaint Manager and CAPA Manager
Weidmann Medical Technology AG
- Handling customer complaints and managing CAPA processes
- Ensuring quality and regulatory compliance
Okt. 2021 - Apr. 2022
7 MonatenRA Manager
Johnson & Johnson
- Managing Swiss exit, contracts, labelling, MDR and registrations
Feb. 2021 - Sept. 2021
8 MonatenRA Manager
Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (BEGO)
- Securing regulatory approvals for Canada, Russia, China, etc.
Sept. 2020 - Jan. 2021
5 MonatenQM Consultant
medi GmbH
- Consulting on MDR and MDSAP
- Preparing technical files
Nov. 2019 - Juni 2020
8 MonatenTechnical Writer, QA
Ulrich Medical GmbH
- Updating technical file to MDR standards
- Managing biocompatibility evaluations and labelling
Mai 2019 - Nov. 2019
7 MonatenRegulatory Affairs Manager
Paul Hartmann AG
- Developing regulatory strategies for MDR and various products
- Preparing responsible documentation
Juni 2018 - Apr. 2019
11 MonatenRegulatory 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 Jahren 4 MonatenQM 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
Mai 2017 - Apr. 2018
1 JahrQA/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
Sept. 2016 - Apr. 2017
8 MonatenQA 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 - Dez. 2015
5 MonatenQA 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
März 2015 - Aug. 2016
1 Jahr 6 MonatenQA 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
Okt. 2014 - Jan. 2015
4 MonatenQA Manager
Johnson & Johnson
- Technical editing for implants sector: quality and CSV documents, sterilisation, validation, and cleaning documentation
Okt. 2013 - Juni 2014
9 MonatenQA 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
Juli 2010 - Sept. 2013
3 Jahren 3 MonatenTechnical Editor
TOX
- Preparing operating instructions, service manuals, and other required documents
- Supporting website content and creating brochures and promotional materials
- SAP user
Dez. 2009 - Juni 2010
7 MonatenCommunication Manager
Commerzbank AG
- Creating internal and external newsletters
- Managing communication flow and planning
- Delivering presentations and leadership in communication projects
Juni 2006 - Nov. 2009
3 Jahren 6 MonatenTechnical 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 - Juni 2006
5 Jahren 6 MonatenJournalist
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 - Dez. 2002
2 JahrenEditor
Lehrinstitut Onken
- Creating textbooks for correspondence courses in PC applications
Jan. 1998 - Dez. 2000
3 JahrenEditor
Vogel Verlag
- Editing and writing articles for CHIP magazine, including product overviews and presentations
Jan. 1997 - Dez. 1998
2 JahrenEditor
Bruchmann Verlag
- Editing and writing articles for ELRAD magazine, including product overviews and presentations
Jan. 1996 - Dez. 1998
2 JahrenTechnical Editor
B.L.E.
- Creating manuals in mechanical engineering sector
Jan. 1992 - Dez. 1997
5 JahrenTechnical 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 - Dez. 1992
2 JahrenElectronic 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 - Dez. 1992
2 JahrenService Technician
Perkin-Elmer
- Providing worldwide service for environmental and process analyzers
- Conducting customer seminars and telephone support
- Creating service messages
Jan. 1986 - Dez. 1991
5 JahrenInformation Electronics Specialist
Bodenseewerk Perkin-Elmer
- Working in electronics production with various responsibilities
Sprachen
Deutsch
Muttersprache
Englisch
Verhandlungssicher
Ausbildung
Okt. 1984 - Sept. 1986
Bfw
Apprenticeship · Information Electronics · Schömberg, Deutschland
Zertifikate & Bescheinigungen
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
Ähnliche Freelancer
Entdecken Sie andere Experten mit ähnlichen Qualifikationen und Erfahrungen.