プロフィール詳細

プロジェクトを作成

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Emilie M.に依頼

France

Regulatory Consultant, PMS & Vigilance for Medical Devices & IVD

プロフィール概要

I am a freelance consultant with over 10 years of experience in regulatory affairs, specializing in Post‑Market Surveillance (PMS) and vigilance compliance for medical devices and in vitro diagnostics (IVD). My expertise spans EU MDR, IVDR, UK MHRA, Health Canada, and FDA regulatory frameworks, with a strong focus on delivering high‑quality, audit‑ready PMS documentation. I support manufacturers, regulatory teams, and clinical departments by drafting and reviewing PMS Plans, PMS Reports, PSURs, PMCF/PMPF Reports, and trend analysis documentation. I also conduct gap analyses, update technical documentation, and provide temporary vigilance coverage during staff transitions or leave periods. I work closely with clinical teams to support vigilance activities during clinical investigations and post‑market clinical follow‑up (PMCF). My background includes collaboration with notified bodies and competent authorities, giving me a comprehensive understanding of both strategic and operational regulatory expectations. I work in both French and English and offer bilingual drafting, review, and compliance support. I operate fully remotely, with occasional travel depending on project needs, and I am available for collaboration with EU, UK, and international clients.

専門分野

• ☆ Trend Analysis
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Risk Management

サービス

• Writing
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Consulting Regulatory Consulting

職務経験

Post-Market Surveillance Specialist

Diagast

6月 2024 - 12月 2025

Post-Market Surveillance Specialist (Consultant at Diagast)

Amarylys

1月 2024 - 6月 2024

PMS Quality Engineer

Quantum Surgical

3月 2022 - 12月 2023

Vigilance officer and quality engineer

Oticon Medical

1月 2020 - 2月 2022

Quality and Regulatory Affairs Consultant at Oticon Medical

Efor Healthcare

5月 2019 - 12月 2019

Quality & Vigilance Manager

Clinique du Campus

8月 2016 - 2月 2019

学歴

Diploma in Clinical Research, Vigilance, and Post-Market Surveillance

For Drug Consulting

3月 2019 - 4月 2019

Master’s Degree in Management ; Quality and Risk Management

Institut Lillois d'Ingénierie de la Santé (ILIS)

9月 2014 - 8月 2016

Bachelor’s Degree in Biomedical Engineering Technology

Institut Lillois d'Ingénierie de la Santé (ILIS)

9月 2011 - 8月 2014

認定資格

• 認定資格の詳細は未入力です。