Regulatory Affairs Manager – IVDR

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Support clinical trial application submission activities with a dedicated focus on IVDR-related processes • Collaborate with subject matter experts to identify IVDR relevance and interpret submission requirements

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Good understanding of IVDR principles, including its structure and key concepts • Detailed knowledge of clinical trial submission processes is desirable but not essential • Ability to perform detailed analysis of protocols and study documents to assess regulatory and operational implications • Strong cross-functional collaboration, stakeholder management, and coordination skills • Ability to manage complex submission activities, competing priorities, and time-sensitive deliverables

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways