Holger Landau

Regulatory Affairs Manger, Quality Manager and Technical Writer

Mols, Switzerland

Experience

Apr 2025 - Present
4 months

Regulatory Affairs Manager

Andreas Hettich GmbH

  • Managing regulatory affairs for medical devices
  • Ensuring compliance with relevant regulations and standards
Jul 2024 - Apr 2025
10 months

CEO

media-tipps GmbH

  • Leading the company’s strategic direction and operations
  • Overseeing business development and client relations
Feb 2024 - Jun 2024
5 months

Audit 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 months

RA Manager

VDW GmbH

  • Managing approvals in different countries
  • Leading Medical Device Regulation (MDR) compliance efforts
Apr 2022 - Sep 2022
6 months

Complaint 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 months

RA Manager

Johnson & Johnson

  • Managing Swiss exit, contracts, labelling, MDR and registrations
Feb 2021 - Sep 2021
8 months

RA Manager

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

  • Securing regulatory approvals for Canada, Russia, China, etc.
Sep 2020 - Jan 2021
5 months

QM Consultant

medi GmbH

  • Consulting on MDR and MDSAP
  • Preparing technical files
Nov 2019 - Jun 2020
8 months

Technical Writer, QA

Ulrich Medical GmbH

  • Updating technical file to MDR standards
  • Managing biocompatibility evaluations and labelling
May 2019 - Nov 2019
7 months

Regulatory Affairs Manager

Paul Hartmann AG

  • Developing regulatory strategies for MDR and various products
  • Preparing responsible documentation
Jun 2018 - Apr 2019
11 months

Regulatory 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 months

QM 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 year

QA/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 months

QA 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 months

QA 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 months

QA 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 months

QA Manager

Johnson & Johnson

  • Technical editing for implants sector: quality and CSV documents, sterilisation, validation, and cleaning documentation
Oct 2013 - Jun 2014
9 months

QA 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 months

Technical 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 months

Communication 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 months

Technical 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 months

Journalist

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 years

Editor

Lehrinstitut Onken

  • Creating textbooks for correspondence courses in PC applications
Jan 1998 - Dec 2000
3 years

Editor

Vogel Verlag

  • Editing and writing articles for CHIP magazine, including product overviews and presentations
Jan 1997 - Dec 1998
2 years

Editor

Bruchmann Verlag

  • Editing and writing articles for ELRAD magazine, including product overviews and presentations
Jan 1996 - Dec 1998
2 years

Technical Editor

B.L.E.

  • Creating manuals in mechanical engineering sector
Jan 1992 - Dec 1997
5 years

Technical 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 years

Electronic 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 years

Service 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 years

Information 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