IVD Documentation Specialist

What are your responsibilities?

  • Writes, edits, reviews and maintains high quality technical and scientific documentation including but not limited to:
    • Technical protocols & reports (e.g. 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
  • Supports the preparation and conduct of formal Design Review review meetings.
  • Edits documents written by others to verify accuracy, consistency, grammar and format, and ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
  • Maintains standardized language and documentation practices that allow for consistent execution of documents.
  • Participates in continuous quality improvement initiatives to drive organizational adoption of new tools and processes for content creation and management.
  • Trains and educates cross-functional project team members on drafting documentation to required IVD standards.
  • Provides additional support for project team activities as needed.

Who are we looking for?

  • Master degree in sciences
  • Minimum 3+ years IVD documentation and/or technical writing experience for a cGxP environement, 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.
  • knowledge of current US and International regulations as it pertains to documentation (e.g. 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
  • Quality mindset
  • Able to organize and plan multiple priorities
  • Fluent in English (oral and in writing), other European languages are an asset
  • PC skills : Advanced MS Word, eDC systems an asset

What does QbD offer you?

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all..

  • Working for the Antwerp Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ through our extensive training package
  • A hip office with air hockey table
  • More muscle mass through our weekly boot camps
  • 32 vacation days that you wish were fewer (because it's great to work here 😉 )
  • In short … We work, we play, we deliver, we are Quality by Design!

Interested? Apply now by sending us your CV and motivation.