Regulatory Affairs Manager IVDR

Regulatory Affairs Manager IVDR ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Regulatory Affairs Manager IVDR - Homebased in the UK/Europe The role will support clinical trial application submission activities with a dedicated focus on IVDR-related processes, particularly for studies involving companion diagnostics or combined clinical trial/IVDR submissions.

What You Will Do: The role will support clinical trial application submission activities with a dedicated focus on IVDR-related processes, particularly for studies involving companion diagnostics or combined clinical trial/IVDR submissions. Your Profile: Deep understanding of IVDR-related processes and their impact on clinical trial submissions. 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. Deep country-specific regulatory expertise is not required; however, the candidate must be able to analyze study protocols and submission documentation to identify IVDR relevance, assess potential Clinical Performance Study impact, and interpret IVDR submission requirements in close collaboration with subject matter experts.

Required qualifications and experience: 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.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include: 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request  here .

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