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Roman Gilb-Regulatory Affairs and Quality Manager

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Voiteg, Romania

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Experience

Mar 2023 - Present

Regulatory Affairs and Quality Manager

Freelancer

Position Summary
Regulatory Affairs and Quality Manager at Freelancer
Industries
Healthcare
Business Areas
Project Management
Quality Assurance
  • 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

Sep 2022 - Mar 2023

Job hunting in the D-A-CH region

  • Relocating to Romania (with all the associated challenges)
Nov 2018 - Sep 2022
Buchs, Switzerland

Regulatory Affairs and Quality Manager

IMT AG

Position Summary
Regulatory Affairs and Quality Manager at IMT AG
Industries
Healthcare
Business Areas
Quality Assurance
  • 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
Gossau, Switzerland

Quality Specialist

Derungslicht AG

Position Summary
Quality Specialist at Derungslicht AG
Industries
Healthcare
Manufacturing
Business Areas
Quality Assurance
  • Standard testing (EN 60601-1)

  • Technical documentation / lab tests

  • EMC measurements

  • Preparation of test reports

  • User and service manuals

Mar 2015 - Dec 2015
Perroy, Switzerland

Service Technician

Med-Innova

Position Summary
Service Technician at Med-Innova
Industries
Healthcare
Business Areas
Operations
  • Maintenance and repair of all hospital beds and patient couches at the Cantonal Hospital of St. Gallen
Apr 2014 - Dec 2014
Germany

Service technician

Praximedico

Position Summary
Service technician at Praximedico
Industries
Healthcare
Business Areas
Operations
  • Servicing of doctors' offices and operating rooms

  • Maintenance and repairs

Feb 2014 - Mar 2014
Uetikon, Switzerland

Elderly care assistant SRK

Haus Wäckerling

Position Summary
Elderly care assistant SRK at Haus Wäckerling
Industries
Healthcare
Business Areas
Customer Service
Aug 2013 - Jan 2014

Looking for a position

Jan 2008 - Dec 2013
Gommiswald, Switzerland

Elderly care assistant SRK

Haldrain AG

Position Summary
Elderly care assistant SRK at Haldrain AG
Industries
Healthcare
Business Areas
Customer Service
Jan 2003 - Dec 2008
Kaltbrunn, Switzerland

All-rounder

Hof Oberkirch

Position Summary
All-rounder at Hof Oberkirch
Industries
Healthcare
Business Areas
Operations
  • Working in assisted living

  • Grounds and facility maintenance tasks

Jan 2000 - Dec 2002

Electrician

Position Summary
Electrician
Industries
Manufacturing
Business Areas
Operations
Production
  • Temp worker in three electrical companies in Karlsruhe, Germany

  • Installations in industry and control cabinet construction

Jan 1998 - Dec 2000
South Africa

Development Aid Worker

Tugela Ferry

Position Summary
Development Aid Worker at Tugela Ferry
Industries
Construction
Food and Beverage
Business Areas
Operations
Production
  • Electrical installations, control system construction, construction work, and starting a bakery
Jan 1997 - Dec 1998
Stuttgart, Germany

Elderly Care Assistant

Mission Society: Helping Others

Position Summary
Elderly Care Assistant at Mission Society: Helping Others
Industries
Healthcare
Business Areas
Customer Service
Jan 1993 - Dec 1997
Stuttgart, Germany

Gardener

Mission Society: Helping Others

Position Summary
Gardener at Mission Society: Helping Others
Industries
Agriculture
Business Areas
Operations
  • Assisted in gardening, electrical installations, and heating controls
Jan 1992 - Dec 1993

Basic Military Service

German Air Force

Position Summary
Basic Military Service at German Air Force
Industries
Aerospace and Defense
Business Areas
Operations

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Healthcare, Manufacturing, Agriculture, Construction, Food and Beverage, and Aerospace and Defense.

Healthcare
Manufacturing
Agriculture
Construction
Food and Beverage
Aerospace and Defense
Profile match chart

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Operations, Quality Assurance, Customer Service, Production, and Project Management.

Operations
Quality Assurance
Customer Service
Production
Project Management
Profile match chart

Skills

  • Very Good Proficiency In Basic Ms Office Applications
  • Helix Alm

Languages

German
Native
English
Advanced
French
Elementary

Education

May 2012 - Sep 2015

Higher Technical School for Medical Technology

Studies to become a medical technician · Medical Technology · Sarnen, Switzerland

Oct 1988 - Jun 1992

Deutsche Bahn AG

Apprenticeship as an energy electronics technician, specializing in plant engineering · Energy electronics, specializing in plant engineering · Karlsruhe, Germany

Oct 1977 - Jun 1988

Primary and secondary school

Intermediate school certificate · Wörth am Rhein, Germany

Statistics

Experience

Total positions 15
Experience in Healthcare 24.5 y
Avg length 2 y 7 m
Longest experience 5 y 11 m

Global Experience

Countries worked in 3 (Switzerland, Germany, South Africa)
Primary country Switzerland

Expertise

Recent roles Regulatory Affairs and Quality Manager, Job hunting in the D-A-CH region, Quality Specialist
Main industries Healthcare, Manufacturing, Agriculture
Main business areas Operations, Quality Assurance, Customer Service

Qualifications

Profile

Created
Last Update

Frequently asked questions

Have questions? Find more information here.

Roman is based in Voiteg, Romania and can operate in on-site, hybrid, and remote work models.
Roman speaks the following languages: German (Native), English (Advanced), French (Elementary).
Roman has at least 34 years of experience. During this time, Roman has worked in at least 13 different roles and for 11 different companies. The average length of individual experience is 2 years and 3 months. Note that Roman may not have shared all experience and actually has more experience.
Based on recent experience, Roman would be well-suited for roles such as: Regulatory Affairs and Quality Manager, Job hunting in the D-A-CH region, Quality Specialist.
Roman's most recent position is Regulatory Affairs and Quality Manager at Freelancer.
In recent years, Roman has worked for Freelancer and IMT AG.
Roman is most experienced in industries like Healthcare, Manufacturing, and Agriculture. Roman also has some experience in Construction, Food and Beverage, and Aerospace and Defense.
Roman is most experienced in business areas like Operations, Quality Assurance, and Customer Service. Roman also has some experience in Production and Project Management.
Roman has recently worked in industries like Healthcare.
Roman has recently worked in business areas like Quality Assurance and Project Management.
Roman attended Higher Technical School for Medical Technology for Medical Technology.
Roman is immediately available full-time for suitable projects.
Roman's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.
To hire Roman, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

800
600
400
200
Rate comparison chart
Market avg: 480-640 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.