Roman Gilb
Regulatory Affairs and Quality Manager
Experience
Regulatory Affairs and Quality Manager
Freelancer
Based in Romania, working for the D-A-CH region
Jan. 2024–May 2024: IEC 60601-1, usability, risk management, EMC, project management, regulatory correspondence, compliance with complex quality instructions; operating tables, surgical lights; mainly remote; Stryker Corporation, D-Tuttlingen
Aug. 2023–Dec. 2023: Optical and mechanical verification including consulting and preparation of compliant documents; endoscopes, minimally invasive instruments; Karl Storz SE & Co. KG, D-Tuttlingen
Job hunting in the D-A-CH region
- Relocating to Romania (with all the associated challenges)
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
Quality Specialist
Derungslicht AG
Standard testing (EN 60601-1)
Technical documentation / lab tests
EMC measurements
Preparation of test reports
User and service manuals
Service Technician
Med-Innova
- Maintenance and repair of all hospital beds and patient couches at the Cantonal Hospital of St. Gallen
Service technician
Praximedico
Servicing of doctors' offices and operating rooms
Maintenance and repairs
Elderly care assistant SRK
Haus Wäckerling
Looking for a position
Elderly care assistant SRK
Haldrain AG
All-rounder
Hof Oberkirch
Working in assisted living
Grounds and facility maintenance tasks
Electrician
Temp worker in three electrical companies in Karlsruhe, Germany
Installations in industry and control cabinet construction
Development Aid Worker
Tugela Ferry
- Electrical installations, control system construction, construction work, and starting a bakery
Elderly Care Assistant
Mission Society: Helping Others
Gardener
Mission Society: Helping Others
- Assisted in gardening, electrical installations, and heating controls
Basic Military Service
German Air Force
Skills
- Very Good Proficiency In Basic Ms Office Applications
- Helix Alm
Languages
Education
Higher Technical School for Medical Technology
Studies to become a medical technician · Medical Technology · Sarnen, Switzerland
Deutsche Bahn AG
Apprenticeship as an energy electronics technician, specializing in plant engineering · Energy electronics, specializing in plant engineering · Karlsruhe, Germany
Primary and secondary school
Intermediate school certificate · Wörth am Rhein, Germany
Profile
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