We are seeking an experienced native Estonian, Slovene/Slovenian medical translator to assist with the translation of medical device Instructions for Use (IFUs) and related technical documentation.
The ideal candidate must be fully familiar with EU MDR (Regulation (EU) 2017/745) requirements, ISO 20417:2021 standards, and regulatory language conventions for medical devices.
Project Details:
Translation from English to Estonian, Slovene/Slovenian
Documents include:
A. Instructions for Use (IFUs)
B. Technical files
C. Cleaning, sterilization, and reprocessing instructions
D. Packaging and labeling content (symbols, warnings, disposal information)
E. Regulatory incident reporting language
F. Strict adherence required to:
- EU MDR 2017/745 standards (Annex I Section 23 "Information Supplied by the Manufacturer")
- ISO 20417:2021 for medical device user information
- ISO :2021 for symbols and labels
- No deviations from source structure, phrasing, formatting, or numbering.
- Deliverables must be: 100% accurate, human-like translations with no omissions, additions, or AI-style phrasing
Requirements:
- Native Estonian, Slovene/Slovenian speaker
- Proven experience in medical device translations (preferably IFUs, technical documentation, labeling texts)
- Deep understanding of MDR and ISO standards (especially for medical device user documentation)
- Ability to produce polished, ready-to-submit translations requiring minimal to no additional revisions
- Extremely attentive to structure, formatting, terminology consistency, and warnings/cautions phrasing
- Ability to proofread carefully against the source text before final delivery
Bonus Skills:
- Experience translating for CE marking submissions under MDR
- Familiarity with translations involving single-use, reusable medical devices, ophthalmic lenses, or surgical instruments
- Experience with labelling symbols (e.g., "Sterilized using ethylene oxide", "Do not reuse") following ISO
Work Style:
- Highly detail-oriented and quality-driven
- Responsible with deadlines and responsive to feedback
- Consistent across multiple related projects (same product family IFUs, packaging inserts, etc.)
To Apply:
Please share:
A brief description of your experience with MDR-compliant medical device translations
Samples of previous translations (preferably IFUs, packaging texts, cleaning/sterilization instructions)
Your rate per 1000 words for translation and proofreading
Availability (hours per week and time zone)
Contract duration of 1 to 3 months.
Mandatory skills: English, Translation, Regulatory Compliance, Documentation, Estonian, English to Estonian Translation, Slovene