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Regulatory Consultant Medical Devices

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05 SEP '23: This organisation is a regulatory consultancy that helps start-ups, medium sized companies and large medical devices and pharmaceutical organisations in supporting their developmental strategies, coordinating procedures, writing key documents and interacting with health authorities. We are currently looking for a Regulatory Consultant for Medical Devices.


Medical Devices


Oss - Netherlands

40 uur per week

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Zo maak jij het verschil

Explore the opportunity of becoming a Regulatory Consultant for Medical Devices, where you can seamlessly blend your scientific background with regulatory expertise. This role immerses you in the global landscape of pharmaceuticals and medical devices/in vitro diagnostics, offering responsibilities such as crafting and updating technical documentation (e.g., PSUR, BSER, CER, RMP) for applications, overseeing authorisation processes and engagements with notified bodies, implementing ISO 13485 Quality Management Systems, performing gap analyses between IVD and medical device directives and regulations, and receiving coaching to embody the organisation’s ethos of a "professional approach with a personal touch.

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Wat jij mee brengt

In this position, you are required to have an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences. Additionally, it is important to have the following competencies:

  • 2-3 years of experience in the medical device/IVD industry, preferably RA/QA;
  • Knowledge of ISO standards;
  • Preferably, audit experience;
  • The eagerness to learn, develop and excel;
  • A flexible and pragmatic personality;
  • The ability to handle stringent deadlines;
  • Writing and editing skills (English);
  • The ability to communicate in a convincing way.

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Jouw voordelen

Are you ready to join a consultancy organisation that contributes to a better world by supporting medical devices and pharmaceutical organisations with their developmental strategies? This organisation offers a competitive salary. Next to this, you will receive:
  • A solid pension scheme;
  • 25 holiday days;
  • Opportunity to learn about the most relevant topics in the field.


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