Consultant – Regulatory Affairs, Medical Devices

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🕒 March 24

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Ividata Life Sciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Ividata Life Sciences is a French life sciences consulting firm founded in 2013 that helps healthcare and pharmaceutical organizations secure, accelerate, and optimize projects across the product lifecycle. The company deploys around 140 consultants across Europe and specializes in three core domains: Biometrics & Data (biostatistics, data science, programming, bioinformatics, data management, HEOR), Clinical Operations (epidemiology, real-world evidence, medical writing, study management, monitoring) and Regulatory Affairs & Pharmacovigilance (regulatory writing, submissions, vigilance, medical device registration and advertising compliance). Ividata provides expert, long-term partnerships and staffing solutions to pharmaceutical companies, biotech firms, and other health-sector actors.

📋 Description

• 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