Roman Gilb
Regulatory Affairs and Quality Manager
Experience
Jan 2024 - May 2024
5 monthsTuttlingen, Germany
Regulatory Affairs and Quality Manager
Stryker Corporation
- IEC 60601-1, usability, risk management, EMC, project management, regulatory correspondence, compliance with complex quality instructions, and more
- operating tables, surgical lights
- mostly remote
Aug 2023 - Dec 2023
5 monthsTuttlingen, Germany
Regulatory Affairs and Quality Manager
Karl Storz SE & Co. KG
- Optical and mechanical verification including consulting and creating compliant documents
- endoscopes, minimally invasive instruments
Mar 2023 - Present
2 years 5 monthsVoiteg, Romania
Freelancer as Regulatory Affairs and Quality Manager
- Based in Romania, working for the D-A-CH region
Sep 2022 - Mar 2023
7 monthsJob seeking in D-A-CH region
- Relocation to Romania (with all related challenges)
Nov 2018 - Sep 2022
3 years 11 monthsBuchs, Switzerland
Regulatory Affairs and Quality Manager
IMT AG
- Verification, validation & specification
- Standards research (IEC 60601-1, IEC 61010-1, …)
- Quality management (ISO 13485, ISO 17025, 21 CFR 820)
- Risk management (ISO 14971) & usability (ISO 62366-1)
- Measurement equipment officer, internal calibrations
Jan 2016 - Oct 2018
2 years 10 monthsGossau, Switzerland
Quality Specialist
Derungslicht AG
- Standards testing (EN 60601-1)
- Technical documentation / lab tests
- EMC measurements
- Creating test reports
- User and service manuals
Mar 2015 - Dec 2015
10 monthsPerroy, Switzerland
Service Technician
Med-Innova
- Maintenance and repair of all hospital beds and patient couches at St. Gallen Cantonal Hospital
Apr 2014 - Dec 2014
9 monthsSpeicher, Switzerland
Service Technician
Praximedico
- Support for medical practices and ORs, maintenance and repairs
Feb 2014 - Mar 2014
2 monthsUetikon, Switzerland
Elderly Care Assistant (SRK)
Haus Wäckerling
Aug 2013 - Jan 2014
6 monthsJob seeking
Jan 2008 - Dec 2013
6 yearsGommiswald, Switzerland
Elderly Care Assistant (SRK)
Haldrain AG
Jan 2003 - Dec 2008
6 yearsKaltbrunn, Switzerland
All-Round Worker
Hof Oberkirch
- Assisted in assisted living, environmental and facility maintenance tasks
Jan 2000 - Dec 2002
3 yearsKarlsruhe, Germany
Electrician
Leiharbeiter in drei Elektrofirmen
- Installations in industry and control cabinet construction
Jan 1998 - Dec 2000
3 yearsTugela Ferry, South Africa
Development Aid Worker
Tugela Ferry
- Electrical installations, control systems, construction work and starting a bakery
Jan 1997 - Dec 1998
2 yearsGermany
Elderly Care Assistant
Missionswerk: Hilfe am Nächsten
Jan 1993 - Dec 1997
5 yearsGermany
Gardener
Missionswerk: Hilfe am Nächsten
- Assisted in gardening, electrical installations and heating controls
Jan 1992 - Dec 1993
2 yearsGermany
Basic Military Service
Deutsche Luftwaffe
Languages
German
NativeEnglish
AdvancedFrench
Elementary Education
May 2012 - Sep 2015
Höhere Fachschule Medizin Technik
Medical Technician · Medical Technology · Sarnen, Switzerland
Oct 1988 - Jun 1992
Deutsche Bahn AG
Apprenticeship as Energy Electronics Technician, specializing in plant engineering · Energy Electronics Technician, specializing in plant engineering · Karlsruhe, Germany
Oct 1977 - Jun 1988
Grund- und Hauptschule
Intermediate School Certificate · Wörth am Rhein, Germany
Certifications & licenses
Advanced training: industrial specialist for PLC technicians
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