Recommended expert
Estelle (Laure Noumsi) Kamwa
Document Management / Document Controlling Specialist
Experience
Document Management / Document Controlling Specialist
- Implement version control, approval workflows, document traceability across departments and project phases; align with ISO 9001 and MDR requirements
- Maintain documentation audit trails; coordinate revision cycles with engineering, QA, regulatory teams; support internal audits and CAPA reviews
- Coordinate preparation, validation, archiving of multilingual technical files and regulatory submissions (English, German, French)
- Facilitate project handover: track engineering changes, align documentation milestones, compile client/regulatory packages
- Enforce confidentiality and data integrity: ensure GDPR compliance, secure archiving, produce document status reports and metadata analytics
LLM-Evaluation & Prompt Engineering Specialist
- Design of evaluation criteria: define quality dimensions (accuracy, relevance, completeness, tone, style, safety); create scoring rubrics, reference completions
- Creation and management of test sets: develop prompt libraries (normal, edge, adversarial); maintain version control, documentation for testing reproducibility
- Manual evaluation of responses: review and score LLM outputs; detect and log hallucinations, bias, errors, safety risks
- Calibration and auditing: train evaluators, monitor inter-annotator agreement; implement QA controls for annotation consistency
- Metrics tracking and reporting: monitor KPIs (win rate, error rate, factual accuracy, harmlessness, helpfulness); produce performance reports with improvement suggestions
- Feedback for model improvement: deliver structured feedback to engineering and research teams; support prompt optimization, model fine-tuning
- Safety and compliance: identify toxic, biased, non-compliant content; propose guardrails, ethical moderation strategies
Product Development, Requirements & Systems Engineer
- Implement system lifecycle models per ISO/IEC 15288 and German V-Modell from concept to retirement for medical devices
- Define functional and technical architectures: create system block diagrams, interface control documents for embedded electromechanical systems
- Ensure design input/output traceability: link stakeholder requirements, design outputs, risk mitigations, verification evidence (e.g., infusion pump development)
- Coordinate cross-functional teams (engineering, QA, usability, regulatory) to integrate risk controls and usability features
- Manage change and configuration: maintain version-controlled workflows, impact analysis for Class IIb diagnostic platforms
- Decompose user needs into system-level requirements with full traceability; lead requirements engineering for rehabilitation robotics
Project Manager
- Project planning and scheduling: develop Gantt diagrams, WBS, critical path analysis with Primavera P6, MS Project
- Milestone tracking: define phases, deliverables, approval gates to control timelines; align cross-functional workflows
- Budget and resource allocation: monitor labor distribution, vendors, CAPEX/OPEX forecasting
- Integrate regulatory compliance planning: embed ISO 13485, MDR, RoHS/REACH/CE requirements with internal QA checkpoints
- Risk identification and mitigation: create risk registers, scoring matrices, contingency plans; collaborate with technical and quality teams
- Stakeholder engagement and reporting: produce multilingual status reports, dashboards, weekly KPI summaries
Regulatory Affairs Consultant & Quality Manager
- Preparation and translation of technical files: Design History Files (DHF), Risk Management Files (RMF), GSPR checklists, Summaries of Safety and Clinical Performance (SSCPs), Clinical Evaluation Reports (CERs)
- Drafting Post-Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-Up (PMCF) documentation per MDR 2017/745
- Implementation of ISO 13485 QMS: develop SOPs, risk assessment tools, audit documentation; integrate CAPA processes
- Oversight of UDI systems, device labeling, multilingual IFUs in line with RoHS, REACH, IEC 62366; ensure EMC compliance (IEC 60601), Machinery Directive 2006/42/EC
- Translation and coordination of multilingual regulatory submissions for notified bodies and authorities
SAP Consultant
- Integrate SAP MM, SD, QM, PP modules: configure transactional workflows, reporting, inter-module coordination
- Implement master data governance: control materials master, BOMs, vendor and customer data for operational efficiency and audit readiness
- Map and optimize end-to-end processes using LSMW, custom T-codes, Fiori apps
- Align SAP workflows with MDR, ISO 13485, RoHS/REACH requirements
- Develop multilingual training manuals, test scripts, provide real-time support to SAP end-users
Software-Testing Specialist
- Design and execute test cases: create test plans, scripts, checklists based on user stories and requirements
- Report and track bugs via Jira, TestRail, Redmine; include screenshots and severity classification
- Conduct cross-browser (Chrome, Firefox, Safari) and mobile (Android, iOS) testing
- Perform multilingual and linguistic QA: verify string length, truncation, contextual fit
- Execute regression testing after patches or UI changes to ensure functionality stability
- Check compliance and accessibility per WCAG, ISO/IEC 25010, EU MDR usability criteria
Technical & Medical Translation & Writing Specialist
- Translation of complex medical and pharmaceutical documentation, including clinical trial protocols, informed consent forms (ICFs), summaries of product characteristics (SmPCs), patient leaflets, pharmacological monographs, and internal documents for hospitals and pharmaceutical labs
- Regulatory writing and technical translation aligned with European and international standards, covering Risk Management Reports, PMS-Plans, CAPA documentation, and Design History Files (DHF); compliance for CE marking, RoHS, REACH, MDR 2017/745, ISO 13485, FDA 21 CFR
- Technical translation and editing for industrial, electronics, and medical technology sectors: operating manuals, installation guides, safety instructions, datasheets, validation protocols
- Documentation preparation and localization for medical devices in compliance with IEC 62366 (usability) and IEC 60601 (EMC); deliverables include IFUs, SSCPs, device labeling, multilingual design files
- Marketing localization, UX writing, and SEO adaptation for digital platforms and e-commerce; product pages, landing pages, e-learning modules, UX flows, onboarding content in English, German, French
Transcription & Subtitling Specialist
- Subtitler at SousTitreur.com: deliver accurate, timely subtitles for media agencies and streaming clients
- Subtitler for Prostitution Research Conference (Berlin 2022): full multilingual video subtitling (EN/DE/ES) including trauma-sensitive content
- Medical Transcriptionist at iMerit: manual and AI-based transcription for healthcare projects (EN ⇄ FR)
- Subtitler & Editor at ElevenLabs: improve AI-generated subtitles for clarity and natural flow
- Subtitler at Infohana: institutional and corporate video subtitling, time-coded captions, quality control
Languages
German
AdvancedEnglish
AdvancedSpanish
AdvancedFrench
AdvancedEducation
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Bachelor's degree, Air-Conditioning, Refrigeration, and Environmental Technology · Mechanical Engineering
Certifications & licenses
AI For Translators – Editions I & II
Basics Of AI & Prompting For Translators And Interpreters
Best Practices Dictating With Dragon
CE Marking & Risk Management For Medical Devices
TÜV Rheinland
CE Marking For Medical Devices
TÜV Rheinland
Change & Configuration Control In Regulated Environments
Internal QA-Workshop
ChatGPT And Bard For Translators
Clinical Trials Explained For Translators (Ed. I & II)
Design & Development Of Medical Devices
TÜV Rheinland
Document Control For Engineering & Construction Projects
Internal Training
Documentation & Engineering Project Experience
EIKO-Anlagenbau- & -Prüfungsgesellschaft MbH
E-Mail-Marketing & Copywriting For Language Professionals
Functional Specifications & Traceability Management
In-house program, Device Master
Fundamentals Of Medicine For Translators
Guide To Translating User Manuals
GxP & SAP Compliance In Regulated Industries
How To Create Error-Free Subtitles
ISO 9001 Quality Management Principles
Introduction To Medical Device Localization
MS Project Training – Microsoft Project Fundamentals & Advanced Online Course
Machinery Directive 2006/42/EC
WEKA-Akademie
Marketing Translation For Pharma Companies
Material Master Data Strategy In SAP
Pharmacology For Translators & Interpreters (Ed. I & II)
Post-Market Surveillance & CAPA
TÜV Rheinland
Post-Market Surveillance & CAPA In MDR
TÜV Rheinland
Primavera P6 Project Management Training
Internal Program / Online Certification
Product Development & Systems Engineering
Internal Program (aligned with INCOSE / ISO/IEC 15288)
Prompt Engineering Tools & Apps For Translators
Regulatory Writing And Documentation In Pharma
Private Modules
Requirements Engineering
IREB / INCOSE Foundations
SAP ERP Fundamentals
SAP Quality Management Processes (QM)
Subtitling: A Comprehensive Course
Technical Documentation For Medical Devices
TÜV Rheinland
Technical Translation And Documentation
Technical Writing: How To Write Software Documentation
The Complete 2025 Software Testing Bootcamp
The Ultimate SAP S/4HANA Course 2025: From Zero To Expert
Transcreation Masterclass (III Ed. 2025)
Typing Test – 33 WPM, 96% Accuracy
Typing.com
Verified Medical Transcription Experience
iMerit Inc.
Writing For Localization & UX Content
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