Regulatory Affairs Manager IVDR

Regulatory Affairs Manager IVDR

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply