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Hire Oskar S.

Czech Republic

USD 75 /hr

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

Profile Summary

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.

Subject Matter Expertise

Services

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

Work Experience

Project Management Officer, CEESAT

Johnson & Johnson

February 2025 - May 2026

Territory Manager, MedTech Division

Johnson & Johnson

June 2023 - January 2025

Clinical Trials Intern, Pharmaceuticals Division

Johnson & Johnson

August 2022 - May 2023

Quality and Regulatory Affairs Specialist

ProSpon

September 2020 - June 2022

Education

MSc Biomedical Engineering

Imperial College London

September 2019 - September 2020

BEng Mechanical Engineering

University of Manchester

September 2016 - June 2019

Certifications

Certification details not provided.