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Documentation Specialist (Technical Writer)/Belgium

Posted on Sep 25, 2019 by Endeavour Recruitment

Mechelen, Antwerpen, Belgium
Immediate Start
€55 - €55 Hourly

The IVD Documentation Specialist will be responsible for writing and reviewing scientific and technical documents to support the development activities of in vitro diagnostic (IVD) products..

Tasks and responsibilities:

Writes, edits, reviews and maintains high quality technical and scientific documentation including but not limited to:

  • Technical protocols & reports (eg analytical assay vertification and validation)
  • Product Specifications
  • Change Reviews
  • Design History File and/or technical file documentation regulatory submissions
  • Briefing documents
  • Quality System documentation including Standard Operating Procedures (SOPs), Instructions, Forms, etc.
  • Provides support in development and review of documents from first draft stages through to an approved document, including:
  • Document planning
  • Interaction/communication with team members
  • Resolution of comments errors and inconsistencies
  • Timely facilitation of document review by stakeholders


  • Bachelor degree in sciences, or equivalent through experience. Master's degree preferred.


  • Minimum 3+ years IVD documentation and/or technical writing experience for a cGxP environment, preferably a Pharmaceuticals or Biotech company.
  • Knowledge and experience with medical devices, regulated software, pharmaceutical or biotechnology industry preferred.
  • Working knowledge with respect to the preparation of documents for submission for marketing approval.

Specific professional knowledge:

  • Knowledge of current US and International regulations as it pertains to documentation (eg FDA, ISO, IVDD, and 21 CRF Part - 11) and control of electronic records is required
  • Working knowledge of Design Controls, ISO13485 and 21
  • Principles of effective scientific communication
  • Basics in laboratory techniques (PCR), oncology or companion diagnostics is a plus
  • Some background in statistics is preferred

Please get in touch for further details.

Reference: 761411572

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