Consultant – Regulatory Affairs, Medical Devices

Role Overview

• Draft and review regulatory documents related to clinical studies
• Contribute to the preparation of submissions to competent authorities
• Ensure document compliance with the Medical Device Regulation (MDR)
• Work closely with clinical and quality teams
• Participate in regulatory strategy related to clinical studies

Requirements

• Minimum 2 years' experience in regulatory affairs and/or medical writing
• Excellent command of regulatory writing applied to clinical studies
• Good knowledge of the regulatory framework for medical devices (MDR 2017/745)
• Experience with clinical submissions
• Proficiency in clinical documents: protocols, Investigator’s Brochure (IB), clinical investigation files
• Ability to work in multi-project environments
• Familiarity with interactions with European authorities (ANSM, EMA) is a plus
• Professional working proficiency in English

Benefits

• Stimulating work environment
• Remote work possible
• Collaboration with passionate experts
• High-impact assignments