Regulatory Affairs Consultant – Medical Device, Combination Product Expert

🔥 0 minutes ago

🌐 Italy, Croatia, +4 more countries – Remote

🇮🇹 Italy – Remote 🇭🇷 Croatia – Remote 🇭🇺 Hungary – Remote 🇱🇹 Lithuania – Remote 🇵🇱 Poland – 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 and technical documentation for medical devices and combination products • Represent the regulatory affairs function 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 device clinical development lifecycle and marketing authorization • Maintain global regulatory databases with accurate and current information • Collaborate with CMC and QA departments on device change control processes and global submission requirements • Support internal and external audits related to medical device quality systems • 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 medical devices and drug-device combination products • In-depth knowledge of global medical device regulations, particularly EU MDR • Proven experience in global regulatory strategy and technical documentation preparation for EU, including clinical investigations, Notified Body opinions, and CE certifications • Familiarity with EU-MDR, ISO 13485, and ISO 14155 • Strong track record representing companies during regulatory audits and inspections • Excellent communication and interpersonal skills • Fluent in English, written and spoken