Regulatory Affairs Consultant, Medical Device IVDR

🔥 0 minutes ago

🌐 Italy, Croatia, +3 more countries – Remote

🇮🇹 Italy – Remote 🇭🇷 Croatia – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Develop comprehensive regulatory strategies for performance evaluation studies • Support preparation of technical documentation for IVD products • Represent regulatory affairs in global project teams and governance meetings • Lead regulatory interactions with health authorities and notified bodies, including documentation preparation and meeting coordination • Manage regulatory activities throughout the IVD clinical development lifecycle and marketing authorization • Maintain global regulatory databases with accurate and current information • Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions • Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function

🎯 Requirements

• University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline • Minimum 5+ years of experience in regulatory affairs for IVD • In-depth knowledge of EU IVDR, ISO 13485 and ISO 20916 • Knowledge of EU MDR regulation, international regulatory framework and experience in medical devices would be a plus • Proven experience in global regulatory strategy and technical documentation preparation for EU, including performance evaluation studies and CE certifications • Strong track record representing companies during regulatory audits and inspections • Excellent communication and interpersonal skills • Fluent in English, written and spoken • Proficiency with regulatory systems including Veeva and TrackWise would be a plus

🏖️ Benefits

• Home or office-based work arrangement • Full-time employment