Technical Documentation Specialist

Technical Documentation Specialist - Unity Partners - Vacatures

Unity Partners on behalf of our MedTech partner

Our partner is an innovative MedTech company developing high-quality devices usedin clinical workflows worldwide. To strengthen their Engineering and QA/RA collaboration, we’re looking for a Technical Documentation Specialist who can translate complex engineering input into clear, compliant product documentation that meets global standards.

As a Technical Documentation Specialist , you will:

·       Own and maintain Design History Files (DHFs) per product/family, including designinputs/outputs, V&V evidence, risk references, and traceability.

·      Draft, structure, and edit Instructions for Use (IFUs) : chaptering, safety information, symbols, labeling content.

·      Create technical illustrations for IFUs and labels (line drawings, exploded views, step-by-step visuals).

·       Facilitate cross-functional reviews with Engineering and QA/RA; process feedback and maintain a clean change history.

·      Ensure documentation compliance with MDR (EU 2017/745) and FDA (21 CFR 820/801) ,aligned with ISO 13485, ISO 14971 and, where applicable, IEC 62366 .

·      Safeguard end-to-end traceability from requirements → V&V → IFU.

·      Bachelor’s or Master’s in Technical Communication, Biomedical/Mechanical Engineering , or related field.

·      Proven experience writing medical device documentation (e.g., DHF/DMR/IFU).

·      Working knowledge of MDR and FDA expectations; audit/submission exposure is a plus.

·      Proficiency with documentation and illustration tools (e.g., Adobe InDesign orsimilar).

·      Excellent written English ; Dutch is a plus.

·      Detail-oriented, structured, and able to clarify complex technical topics; strong sense of ownership .

Join a skilled,supportive team with short decision lines where you’ll have real ownership over documentation that directly impacts patient safety and regulatory compliance .

You can expect competitive salary and pension plan, hybrid working possibilities and a collaborative environment focused on quality, clarity, and compliance

Reachout to  Christian Steenkamp  via [staat bij de werkgever] or [staat bij de werkgever] for more information or to apply directly

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