Overview

• Founded in 2023 and headquartered in Paris, MDrec operates as a solo-employee staffing and recruiting firm specializing in medical device sectors
• Maintains a network of nearly 5,000 candidates with expertise in medical device regulatory frameworks and quality systems
• Focuses on professionals with 4+ years of experience in compliance with ANSM, FDA, EMA, and other global health authorities
• Recruits candidates proficient in CE technical files, FDA 510(k) submissions, and MDR 2017/745/IVDR 2017/746 regulations
• Targets professionals skilled in ISO 13485, ISO 14971, and IEC 60601 standards for medical device quality assurance

Specializations

• Medical Device Regulatory Affairs recruitment with emphasis on FDA 510(k) and MDR/IVDR compliance
• Quality Assurance staffing for ISO 13485:2016 and 21 CFR Part 820 implementations
• Healthcare Compliance recruitment focusing on MDSAP participation and CAPA management
• Post-market surveillance (PMS) and materiovigilance specialists for medical device safety monitoring

Services & Approach

• Headhunting for regulatory affairs professionals with ANSM/FDA/EMA compliance expertise
• Candidate sourcing for technical documentation specialists in CE marking and FDA submissions
• Recruitment of quality managers experienced in ISO 14971 risk management and IEC 62304 software lifecycle processes
• Staffing solutions for clinical evaluation report (CER) and periodic safety update report (PSUR) authors