Profile Details

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USD 100 /hr

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Hire Emilie M.

France

USD 100 /hr

Regulatory Consultant, PMS & Vigilance for Medical Devices & IVD

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• Writing
• Consulting

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

Consulting Regulatory Consulting

Work Experience

Post-Market Surveillance Specialist

Diagast

June 2024 - December 2025

Post-Market Surveillance Specialist (Consultant at Diagast)

Amarylys

January 2024 - June 2024

PMS Quality Engineer

Quantum Surgical

March 2022 - December 2023

Vigilance officer and quality engineer

Oticon Medical

January 2020 - February 2022

Quality and Regulatory Affairs Consultant at Oticon Medical

Efor Healthcare

May 2019 - December 2019

Quality & Vigilance Manager

Clinique du Campus

August 2016 - February 2019

Education

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

For Drug Consulting

March 2019 - April 2019

Master’s Degree in Management ; Quality and Risk Management

Institut Lillois d'Ingénierie de la Santé (ILIS)

September 2014 - August 2016

Bachelor’s Degree in Biomedical Engineering Technology

Institut Lillois d'Ingénierie de la Santé (ILIS)

September 2011 - August 2014

Certifications

• Certification details not provided.