Documentation Specialist (Technical Writer)/Belgium
Posted on Sep 25, 2019 by Endeavour Recruitment
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.