プロフィール詳細

プロジェクトを作成

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Oskar S.に依頼

Czech Republic

EU MDR Regulatory Affairs Consultant — Clinical Evaluation, Literature Reviews & Technical Documentation

プロフィール概要

Regulatory affairs specialist with hands-on experience taking medical device manufacturers through the EU MDR transition. In my Quality & Regulatory Affairs role I prepared a manufacturer for the tightened MDR requirements and was directly responsible for passing two external notified-body audits with the fewest findings in the company's history, enabling the launch of new product lines. I pair this regulatory depth with a MedTech commercial and clinical background from Johnson & Johnson, where I worked across the surgical technologies business and co-monitored clinical trials — so I understand both the compliance detail and the commercial context around a device. I help manufacturers with: Clinical Evaluation Reports (MEDDEV 2.7/1 Rev 4), documented PRISMA-style literature searches and reviews, technical documentation and files, MDR gap assessments and CE-marking transition, and post-market surveillance (PMS plans, PSURs). I hold an MSc in Biomedical Engineering from Imperial College London and a BEng in Mechanical Engineering from the University of Manchester. I'm currently also building AI tooling for MDR literature review and vigilance, so I stay close to current regulatory workflows.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971

サービス

• Writing
• Research
• Consulting

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

Research Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

職務経験

Project Management Officer, CEESAT

Johnson & Johnson

2月 2025 - 5月 2026

Territory Manager, MedTech Division

Johnson & Johnson

6月 2023 - 1月 2025

Clinical Trials Intern, Pharmaceuticals Division

Johnson & Johnson

8月 2022 - 5月 2023

Quality and Regulatory Affairs Specialist

ProSpon

9月 2020 - 6月 2022

学歴

MSc Biomedical Engineering

Imperial College London

9月 2019 - 9月 2020

BEng Mechanical Engineering

University of Manchester

9月 2016 - 6月 2019

認定資格

• 認定資格の詳細は未入力です。