• Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

+31 (0)71 528 01 12

Contact us

About BioTop Medical

  • History
  • Our Team
  • Jobs
  • Mission
  • Links
  • Let us help you with your documents

For direct contact call
+31 (0)71 528 01 12

About BioTop Medical

Jobs

Consultant – Regulatory Affairs and Quality Management System for Medical Devices

You will, among many other things…

  • Support companies in bringing their medical devices to (and keeping them on) the EU and other markets, by helping them develop, implement and maintain their quality management system (QMS) and by writing and compiling the Technical Documentation (TD) of their medical devices.
  • Support these companies by explaining the regulations and how to comply with them.
  • Use your knowledge and interpersonal skills to communicate with, advise, teach, and coach clients.
  • Contribute to placing safe and effective medical devices on the market.

You have...

  • A Ph.D. or a Master’s in a relevant field (e.g., but not limited to life science).
  • A firm desire to become an expert in the field.
  • High proficiency in English.
  • A preference for writing.

Why work at BioTop Medical?

BioTop Medical provides a good work environment if you like…

  • To read and write.
  • A small personal team where you have a name and not just a number.
  • A flat company structure where the owner does the same work as you do.
  • Quick access to your colleagues, who are always happy to discuss projects.
  • To lead projects concerning different medical devices.

If you would be interested in working in our company, please send us your CV at: info@biotopmedical.nl

Get in touch

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

Quality Managment System

  • QMS Implementation
  • Auditing

Technical Documentation

  • Medical Devices Regulations
    • Risk management
    • Clinical evaluation
    • Biological Safety Asessment
    • Other
  • In-Vitro Diagnostic Devices Regulations
    • Risk management
    • Performance evaluation
    • Other

Let us help with your documents

  • We conduct literature searches
  • We collect and assess clinical datasets and write clinical evaluation reports (CERs)
  • We lead and oversee the risk management process
  • We write the biological safety assessment report
  • We prepare your technical documentation
  • BioTop Medical © 2023
  • Website by Secure Design
  • Please read our disclaimer
Contact us
  • Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

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