Description

I support medtech, digital health and medical device teamss with EU MDR clinical evaluation and post-market documentation: CEP/CER, SoTA, PMCF/PMS deliverables, PSUR inputs, and systematic literature reviews.

My focus is inspection-ready evidence: clear claims, traceable references, and consistent alignment across intended use, IFU/labeling, risk management (ISO 14971), usability evidence, and real-world/post-market signals.

I also build lighter-weight systems that reduce cycle time: standardized templates, evidence repositories, and QC checklists, useful for teams scaling documentation across portfolios.

- CER/CEP Gap Assessment Sprint (fixed scope): review existing docs + provide a prioritized gap list, evidence plan, and update roadmap.

- SoTA + Comparator Landscape: structured narrative + evidence tables + key endpoints + gap statements for CER support.

- SLR Package (targeted): search strategy, PRISMA screening, extraction tables, appraisal, and synthesis.

- PMS/PMCF Document Pack: PMCF plan outline + PMS inputs + PSUR-ready sections and evidence traceability support.

Industry field of expertise

Languages

English
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

Aptar Digital Health
Technical Medical Writer
MEDICAL
August 2025 - Today (1 year)
Eu, France
As a technical medical writer within Medical Affairs at Aptar Digital Health, managing clinical and regulatory documentation for range of medical devices. My role focuses on building and maintaining inspection-ready clinical evidence
files under EU MDR and FDA requirements while keeping documentation aligned with evolving product, data, and regulatory requirements.
Writing Proofreading/Editing Data analysis
Multiple Universities
Freelance Consultant Academic Research & Medical Writing Support
September 2024 - Today (1 year and 11 months)
London, UK
• - Provide end-to-end support to clinical and academic research teams across infectious diseases, HIV, and medical devices, including manuscript development, ethics proposals, study design input, and data interpretation for peer-reviewed publications.
CLIN-r+
Medical Writer and Clinical Research
May 2022 - March 2025 (2 years and 10 months)
Greater London, UK
As a Medical Writer and Researcher, I develop comprehensive State-of-the Art (SoTA) reviews, Clinical Evaluation Reports (CERs), Systematic Literature Reviews (SLRs), and Post-Market Surveillance (PMS) deliverables. My work ensures alignment with EU MDR and supports regulatory compliance across the product lifecycle. I also produce Vigilance System Reports (VSRs) and Periodic Safety Update Reports (PSURs), contributing to the ongoing safety and effectiveness of high-risk medical devices.