Technical Documentation Specialist

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.

Key Responsibilities

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.

Your Profile

·      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.

Organization & Offer

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

Interested?

Reachout to Christian Steenkamp via christian@unitypartners.nl or +31 (0)208938 606 for more information or to apply directly

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