Freelance Translator and Consultant

Over 15 years of experience in medical and technical translation, regulatory writing, and specialized documentation for healthcare, pharmaceutical, biotech, and industrial sectors.

Translation of complex medical and pharmaceutical documentation, including clinical trial protocols, informed consent forms, summaries of product characteristics, patient leaflets, pharmacological monographs, and internal lab documents.

Regulatory writing and technical translation aligned with European and international standards, covering risk management reports, PMS plans, CAPA documentation, design history files, and compliance for CE marking, RoHS, REACH, MDR 2017/745, ISO 13485, and FDA 21 CFR.

Technical translation and editing of operating manuals, installation guides, safety instructions, datasheets, validation protocols, and multilingual design files for medical devices and industrial equipment.

Documentation preparation and localization for medical devices in compliance with IEC 62366 (usability) and IEC 60601 (EMC), delivering IFUs, SSCPs, device labeling, and multilingual design files.

Marketing localization, UX writing, and SEO adaptation for digital platforms and e-commerce in English, German, and French, covering product pages, landing pages, e-learning modules, UX flows, and onboarding content.

LLM evaluation and prompt engineering: design of evaluation criteria, creation and management of test sets, manual evaluation of responses, calibration and auditing, metrics tracking and reporting, feedback for model improvement, and safety & compliance strategies.

Multilingual transcription and subtitling, including sensitive medical and corporate content. Roles include subtitler at SousTitreur.com, Prostitution Research Conference (Berlin, 2022), medical transcriptionist for iMerit, and subtitler & editor for ElevenLabs and Infohana.

Regulatory affairs consultancy and quality management: preparation and translation of technical files, post-market surveillance and vigilance, QMS implementation (ISO 13485), labeling and risk compliance (UDI, RoHS, IEC 62366, IEC 60601), and multilingual regulatory submissions.

Document management and control: implementation of version control, approval workflows, document traceability, multilingual technical documentation, project documentation handover, confidentiality and data integrity, audit support, and metadata analytics.

Project management in regulated environments: planning, scheduling, milestone tracking, budget and resource allocation, regulatory compliance integration, risk identification and mitigation, stakeholder engagement and reporting, agile methodologies, and innovation methods.

Product development, requirements, and systems engineering: system lifecycle management (ISO/IEC 15288, V-Model), architecture definition, input/output traceability, cross-functional collaboration, change & configuration management, requirements specification, and systems engineering in medical technology (ISO 14971, IEC 62366, IEC 62304).

SAP consultancy: expertise in SAP MM, SD, QM, PP, master data governance, process mapping and optimization, regulatory alignment, and user training in ECC 6.0 and S/4HANA environments.

Software testing: manual testing, UX validation, regression testing, multilingual LQA testing, cross-browser and mobile testing, compliance and accessibility checks, test case design, bug reporting, and tracking.